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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Dual Screw Buttress Plate
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP2281 ()
  • M719GBP2280 ()

  • Length: 28 Millimeter
GBP2-28

  • Bone-screw internal spinal fixation system, non-sterile
Single Screw Buttress Plate
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GBP1280 ()
  • M719GBP1281 ()

  • Length: 28 Millimeter
GBP1-28

  • Bone-screw internal spinal fixation system, non-sterile
22X26X15 12 DEG SPECIALTY TRIAL ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0097
In Commercial Distribution

  • M697C08000970 ()
  • M697C08000971 ()

  • Angle: 12 degree
  • Width: 22 Millimeter
  • Length: 26 Millimeter
  • Height: 15 Millimeter


  • Polymeric spinal interbody fusion cage
38X28 SPECIALTY IRIX A 30 DEG INSERTER TIP
Xtant Medical Holdings, Inc.
C080-0083
In Commercial Distribution

  • M697C08000830 ()
  • M697C08000831 ()

  • Angle: 30 degree
  • Width: 38 Millimeter
  • Length: 28 Millimeter


  • Polymeric spinal interbody fusion cage
15MM SPECIALTY PADDLE STYLE TRIAL ASSEMBLY
Xtant Medical Holdings, Inc.
C034-0215
In Commercial Distribution

  • M697C03402150 ()
  • M697C03402151 ()

  • Height: 15 Millimeter


  • Polymeric spinal interbody fusion cage
28mm x 10mm x 16mm TLIF RASP
Xtant Medical Holdings, Inc.
X034-0370
In Commercial Distribution

  • M697X03403700 ()
  • M697X03403701 ()

  • Height: 16 Millimeter
  • Width: 10 Millimeter
  • Length: 28 Millimeter


  • Polymeric spinal interbody fusion cage
28mm x 10mm x 15mm TLIF RASP
Xtant Medical Holdings, Inc.
X034-0369
In Commercial Distribution

  • M697X03403690 ()
  • M697X03403691 ()

  • Height: 15 Millimeter
  • Length: 28 Millimeter
  • Width: 10 Millimeter


  • Polymeric spinal interbody fusion cage
28mm x 10mm x 14mm TLIF RASP
Xtant Medical Holdings, Inc.
X034-0368
In Commercial Distribution

  • M697X03403680 ()
  • M697X03403681 ()

  • Height: 14 Millimeter
  • Width: 10 Millimeter
  • Length: 28 Millimeter


  • Polymeric spinal interbody fusion cage
28mm x 10mm x 13mm TLIF RASP
Xtant Medical Holdings, Inc.
X034-0367
In Commercial Distribution

  • M697X03403670 ()
  • M697X03403671 ()

  • Width: 10 Millimeter
  • Height: 13 Millimeter
  • Length: 28 Millimeter


  • Polymeric spinal interbody fusion cage
28mm x 10mm x 12mm TLIF RASP
Xtant Medical Holdings, Inc.
X034-0366
In Commercial Distribution

  • M697X03403660 ()
  • M697X03403661 ()

  • Height: 12 Millimeter
  • Length: 28 Millimeter
  • Width: 10 Millimeter


  • Polymeric spinal interbody fusion cage
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