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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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, 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 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 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 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 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 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 14X35X08 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-1435-0008
In Commercial Distribution

  • 00810135960786 ()

  • Height: 8 Millimeter
  • Depth: 14 Millimeter
  • Width: 35 Millimeter


  • General internal orthopaedic fixation system implantation kit
RETRACTABLE OSTEOTOME. 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-O
In Commercial Distribution

  • 00810135960649 ()


  • Orthopaedic osteotome
EARP INITIAL INSERTER. 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-II
In Commercial Distribution

  • 00810135960625 ()


  • General internal orthopaedic fixation system implantation kit
EARP DISC SPACER 10MM 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-DS-001-10
In Commercial Distribution

  • 00810135960588 ()


  • General internal orthopaedic fixation system implantation kit
EARP DISC SPACER 8MM 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-DS-001-08
In Commercial Distribution

  • 00810135960571 ()


  • General internal orthopaedic fixation system implantation kit
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Drive Headstage
In Commercial Distribution

  • 07290114061520 ()
700-006000-00

  • Depth electrode
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
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-409
In Commercial Distribution

  • 09348215058098 ()


  • Instrument tray, reusable
DEVEX SYSTEM CAGE FILLER BLOCK
DEPUY SPINE, LLC
286409000
Not in Commercial Distribution

  • 10705034212470 ()
286409000

  • Bone graft packing block
MICROWIRE DEPTHALON ELECTRODE, 48 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-07-48-001-NS
In Commercial Distribution

  • 00650551143727 ()

  • Microwire Diameter 25 Micrometer
  • Main Tube Length 20 Centimeter
  • Contact Size 5 Millimeter
2104-07-48-001-NS

  • Depth electrode
sEEG, PLATINUM, 8 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-08-111-NS
In Commercial Distribution

  • 00650551142843 ()

  • Main Tube Length 27 Centimeter
  • Spacing 0.9 Millimeter
  • Recording Depth 16.7 Millimeter
  • Contact Length 1.3 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-08-111-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 48 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-16-48-002-NS
In Commercial Distribution

  • 00650551142805 ()

  • Microwire Diameter 25 Micrometer
  • Main Tube Length 9 Centimeter
  • Contact Size 0.5 Millimeter
2104-16-48-002-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 4 CONTACT, NON-STANDARD CONNECTOR
PMT CORPORATION
2102-04-002-NS
In Commercial Distribution

  • 00650551142638 ()

  • Main Tube Length 22 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 17 Millimeter
  • Contact Length 2 Millimeter
2102-04-002-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL, 27.25MM SPACING BETWEEN CONTACTS #8 & #9
PMT CORPORATION
2102-16-134-NS
In Commercial Distribution

  • 00650551142461 ()

  • Main Tube Length 55 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-134-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-157-NS
In Commercial Distribution

  • 00650551142133 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 85 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-157-NS

  • Depth electrode
sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-155-NS
In Commercial Distribution

  • 00650551139881 ()

  • Main Tube Length 27 Centimeter
  • Spacing 6 Millimeter
  • Recording Depth 74 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-155-NS

  • Depth electrode
sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-149-NS
In Commercial Distribution

  • 00650551139867 ()

  • Main Tube Length 27 Centimeter
  • Spacing 4 Millimeter
  • Recording Depth 56 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-149-NS

  • Depth electrode
sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-148-NS
In Commercial Distribution

  • 00650551139843 ()

  • Main Tube Length 27 Centimeter
  • Spacing 2 Millimeter
  • Recording Depth 38 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-148-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-112-NS
In Commercial Distribution

  • 00650551137504 ()

  • Main Tube Length 27 Centimeter
  • Spacing 1.37 Millimeter
  • Recording Depth 41.3 Millimeter
  • Contact Length 1.3 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-112-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 36MM SPACING BETWEEN CONTACTS #13 & #14
PMT CORPORATION
2102-16-154-NS
In Commercial Distribution

  • 00650551131496 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3 Millimeter
  • Recording Depth 110 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-154-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 13.98MM SPACING BETWEEN CONTACTS #13 AND #14
PMT CORPORATION
2102-16-152-NS
In Commercial Distribution

  • 00650551131472 ()

  • Main Tube Length 27 Centimeter
  • Spacing 2.43 Millimeter
  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-152-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.1MM DRILL, 12MM SPACING BETWEEN CONTACTS #13 AND #14
PMT CORPORATION
2102-16-151-NS
In Commercial Distribution

  • 00650551131465 ()

  • Main Tube Length 27 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 65 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-151-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-142-NS
In Commercial Distribution

  • 00650551131441 ()

  • Main Tube Length 27 Centimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 85 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-142-NS

  • Depth electrode
sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-131-NS
In Commercial Distribution

  • 00650551131403 ()

  • Main Tube Length 60 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 33.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-131-NS

  • Depth electrode
sEEG, PLATINUM, 8 CONTACT, MINI CONNECTOR, REMOVEABLE STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-08-131-NS
In Commercial Distribution

  • 00650551131397 ()

  • Main Tube Length 60 Centimeter
  • Spacing 1.5 Millimeter
  • Recording Depth 26.5 Millimeter
  • Contact Length 2 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-08-131-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 8 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-08-IL-SS-M2-NS
In Commercial Distribution

  • 00650551070351 ()

  • Contact Length 2 Millimeter
  • Main Tube Length 32 Centimeter
  • Spacing 5 Millimeter
  • Recording Depth 37 Millimeter
2102-08-IL-SS-M2-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 4 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-04-IL-SS-M2-NS
In Commercial Distribution

  • 00650551070344 ()

  • Recording Depth 44 Millimeter
  • Spacing 10 Millimeter
  • Main Tube Length 32 Centimeter
  • Contact Length 5 Millimeter
2102-04-IL-SS-M2-NS

  • Depth electrode
DEPTH ELECTRODE, PLATINUM, 6 CONTACT, MINI CONNECTOR, MEG 2
PMT CORPORATION
2102-06-IL-SS-M2-NS
In Commercial Distribution

  • 00650551070337 ()

  • Contact Length 5 Millimeter
  • Main Tube Length 32 Centimeter
  • Spacing 10 Millimeter
  • Recording Depth 55 Millimeter
2102-06-IL-SS-M2-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-108-NS
In Commercial Distribution

  • 00650551070320 ()

  • Recording Depth 90 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
2102-16-108-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-098-NS
In Commercial Distribution

  • 00650551070313 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 90 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-16-098-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-107-NS
In Commercial Distribution

  • 00650551070306 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 80 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-16-107-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-097-NS
In Commercial Distribution

  • 00650551070290 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 80 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-097-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-106-NS
In Commercial Distribution

  • 00650551070283 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 68.5 Millimeter
  • Spacing 4.43 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-106-NS

  • Depth electrode
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