Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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DEPTH ELECTRODE, PLATINUM, 3 CONTACT, MINI CONNECTOR
PMT CORPORATION
2102-03-082-NS
In Commercial Distribution

  • 00650551068624 ()

  • Main Tube Length 32 Centimeter
  • Contact Length 5 Millimeter
  • Recording Depth 25 Millimeter
  • Spacing 10 Millimeter
2102-03-082-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 2 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-02-IL-SS-NS
In Commercial Distribution

  • 00650551068617 ()

  • Spacing 10 Millimeter
  • Recording Depth 15 Millimeter
  • Contact Length 5 Millimeter
  • Main Tube Length 32 Centimeter
2102-02-IL-SS-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 2 CONTACT, IOM CONNECTOR
PMT CORPORATION
2102-02-077-NS
In Commercial Distribution

  • 00650551068600 ()

  • Spacing 15 Millimeter
  • Recording Depth 17 Millimeter
  • Contact Length 2 Millimeter
2102-02-077-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, TIP ONLY, IOM CONNECTOR
PMT CORPORATION
2102-01-078-NS
In Commercial Distribution

  • 00650551068594 ()

  • Contact Length 2 Millimeter
  • Main Tube Length 32 Centimeter
2102-01-078-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, TIP ONLY, INLINE CONNECTOR
PMT CORPORATION
2102-01-037-NS
In Commercial Distribution

  • 00650551068587 ()

  • Main Tube Length 36 Centimeter
  • Contact Length 2 Millimeter
2102-01-037-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, TIP ONLY, INLINE CONNECTOR
PMT CORPORATION
2102-01-032-NS
In Commercial Distribution

  • 00650551068570 ()

  • Main Tube Length 32 Centimeter
  • Contact Length 5 Millimeter
2102-01-032-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, TIP ONLY, MINI CONNECTOR
PMT CORPORATION
2102-01-012-NS
In Commercial Distribution

  • 00650551068563 ()

  • Contact Length 5 Millimeter
  • Main Tube Length 32 Centimeter
2102-01-012-NS

  • Depth electrode
DEVEX SYSTEM CAGE FILLER BLOCK
DEPUY SPINE, LLC
286409000
Not in Commercial Distribution

  • 10705034212470 ()
286409000

  • Bone graft packing block
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-409
In Commercial Distribution

  • 09348215058098 ()


  • Instrument tray, reusable
Depthalon Electrode, Platinum, Non-sterile, 8 Macro Contacts, 16 Microwire contacts, 38.5mm recording length, Inline connector, 1 exit, 2 leads, 2 exits
PMT CORPORATION
2104-08-16-003-NS
In Commercial Distribution

  • 00650551144403 ()


  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Drive Headstage
In Commercial Distribution

  • 07290114061520 ()
700-006000-00

  • Depth electrode
EARP RETRACTOR TRAY. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-TRAY02-XXX
In Commercial Distribution

  • 00810135961103 ()


  • Surgical instrument/implant rack
EARP INSTRUMENT AND IMPLANT TRAY. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-TRAY01-XXX
In Commercial Distribution

  • 00810135961097 ()


  • Surgical instrument/implant rack
EARP DISC RAKE ANGLED. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-DRA
In Commercial Distribution

  • 00810135961059 ()

  • Width: 35 Millimeter
  • Depth: 22 Millimeter
  • Height: 14 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP DISC RAKE The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-DR
In Commercial Distribution

  • 00810135961042 ()

  • Width: 35 Millimeter
  • Depth: 22 Millimeter
  • Height: 14 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, IMPLANT CADDIE 22X45. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-IC_2245
In Commercial Distribution

  • 00810135961035 ()


  • Surgical instrument/implant rack
EARP, IMPLANT CADDIE 22X40. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-IC_2240
In Commercial Distribution

  • 00810135961028 ()


  • Surgical instrument/implant rack
EARP, IMPLANT CADDIE 22X35. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-IC_2235
In Commercial Distribution

  • 00810135961011 ()


  • Surgical instrument/implant rack
EARP, IMPLANT CADDIE 18X45. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-IC_1845
In Commercial Distribution

  • 00810135961004 ()


  • Surgical instrument/implant rack
EARP, IMPLANT CADDIE 18X40. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-IC_1840
In Commercial Distribution

  • 00810135960991 ()


  • Surgical instrument/implant rack
EARP, IMPLANT CADDIE 18X35. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-IC_1835
In Commercial Distribution

  • 00810135960984 ()


  • Surgical instrument/implant rack
EARP, IMPLANT CADDIE 18X30. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-IC_1830
In Commercial Distribution

  • 00810135960977 ()


  • Surgical instrument/implant rack
EARP, IMPLANT CADDIE 14X40. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-IC_1440
In Commercial Distribution

  • 00810135960960 ()


  • Surgical instrument/implant rack
EARP, IMPLANT CADDIE 14X35. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-IC_1435
In Commercial Distribution

  • 00810135960953 ()


  • Surgical instrument/implant rack
EARP, IMPLANT CADDIE 14X30. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-IC_1430
In Commercial Distribution

  • 00810135960946 ()


  • Surgical instrument/implant rack
EARP, IMPLANT CADDIE 14X25. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-IC_1425
In Commercial Distribution

  • 00810135960939 ()


  • Surgical instrument/implant rack
EARP, DISC SPACER CADDIE. The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-DC
In Commercial Distribution

  • 00810135960922 ()


  • Surgical instrument/implant rack
EARP, TRIAL CADDIE The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-TC
In Commercial Distribution

  • 00810135960915 ()


  • Surgical instrument/implant rack
EARP, TRIAL 22X35X14 12° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-2235-1214
In Commercial Distribution

  • 00810135960908 ()

  • Width: 35 Millimeter
  • Depth: 22 Millimeter
  • Height: 14 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 22X35X12 12° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-2235-1212
In Commercial Distribution

  • 00810135960892 ()

  • Width: 35 Millimeter
  • Depth: 22 Millimeter
  • Height: 12 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 22X35X14 6° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-2235-0614
In Commercial Distribution

  • 00810135960885 ()

  • Width: 35 Millimeter
  • Depth: 22 Millimeter
  • Height: 14 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 22X35X12 6° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-2235-0612
In Commercial Distribution

  • 00810135960878 ()

  • Width: 35 Millimeter
  • Depth: 22 Millimeter
  • Height: 12 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 22X35X10 6° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-2235-0610
In Commercial Distribution

  • 00810135960861 ()

  • Width: 35 Millimeter
  • Depth: 22 Millimeter
  • Height: 10 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 18X35X14 12° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-1835-1214
In Commercial Distribution

  • 00810135960854 ()

  • Width: 35 Millimeter
  • Depth: 18 Millimeter
  • Height: 14 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 18X35X12 12° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-1835-1212
In Commercial Distribution

  • 00810135960847 ()

  • Width: 35 Millimeter
  • Depth: 18 Millimeter
  • Height: 12 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 18X35X14 6° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-1835-0614
In Commercial Distribution

  • 00810135960830 ()

  • Width: 35 Millimeter
  • Depth: 18 Millimeter
  • Height: 14 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 18X35X12 6° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-1835-0612
In Commercial Distribution

  • 00810135960823 ()

  • Width: 35 Millimeter
  • Depth: 18 Millimeter
  • Height: 12 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 18X35X10 6° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-1835-0610
In Commercial Distribution

  • 00810135960816 ()

  • Width: 35 Millimeter
  • Depth: 18 Millimeter
  • Height: 10 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 18X35X08 0° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-1835-0008
In Commercial Distribution

  • 00810135960809 ()

  • Width: 35 Millimeter
  • Depth: 18 Millimeter
  • Height: 8 Millimeter


  • General internal orthopaedic fixation system implantation kit
EARP, TRIAL 14X35X10 0° The EARP Interbody System is intended for intervertebral body fusion in the lumbar spine in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 of the lumbosacral spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment prior to treatment with an intervertebral cage. DDD patients may also have Grade 1 spondylolisthesis or retrolisthesis at involved levels. The device system must be used with supplemental fixation and autograft to facilitate fusion and is implanted via a posterolateral approach.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
EARP-T-1435-0010
In Commercial Distribution

  • 00810135960793 ()

  • Depth: 14 Millimeter
  • Width: 35 Millimeter
  • Height: 10 Millimeter


  • General internal orthopaedic fixation system implantation kit
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