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 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, 40 MICROWIRE CONTACTS, 2 X 32 POSITION CONNECTORS
PMT CORPORATION
2104-24-40-002-NS
In Commercial Distribution

  • 00650551096047 ()

  • Main Tube Length 7.3 Centimeter
  • Microwire Diameter 25 Micrometer
  • Contact Size 2 & 0.5 Millimeter
2104-24-40-002-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 12 MICROWIRE CONTACTS, INLINE TAILS WITH 10CM LEADS
PMT CORPORATION
2104-14-12-001-NS
In Commercial Distribution

  • 00650551096030 ()

  • Contact Size 2 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 25 Centimeter
2104-14-12-001-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 10 MICROWIRE CONTACTS, INLINE TAILS WITH 10CM LEADS
PMT CORPORATION
2104-12-10-001-NS
In Commercial Distribution

  • 00650551096023 ()

  • Main Tube Length 20 Centimeter
  • Microwire Diameter 40 Micrometer
  • Contact Size 2 Millimeter
2104-12-10-001-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 14 MICROWIRE CONTACTS, INLINE CONNECTOR WITH 10CM LEAD
PMT CORPORATION
2104-10-14-001-NS
In Commercial Distribution

  • 00650551096016 ()

  • Contact Size 2 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 24 Centimeter
2104-10-14-001-NS

  • Depth electrode
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