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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7/8mm Double End 16 x 13 Lordotic Trial Assy
Xtant Medical Holdings, Inc.
C066-0042
In Commercial Distribution

  • M697C06600420 ()
  • M697C06600421 ()

  • Height: 8 Millimeter
  • Height: 7 Millimeter
  • Width: 16 Millimeter
  • Length: 13 Millimeter


  • Metallic spinal fusion cage, non-sterile
5/6mm Double End 16 x 13 Lordotic Trial Assy
Xtant Medical Holdings, Inc.
C066-0041
In Commercial Distribution

  • M697C06600410 ()
  • M697C06600411 ()

  • Height: 6 Millimeter
  • Height: 5 Millimeter
  • Width: 16 Millimeter
  • Length: 13 Millimeter


  • Metallic spinal fusion cage, non-sterile
AXLE-X LOCKING PLATE ASSEMBLY, 40MM, 16MM
Xtant Medical Holdings, Inc.
X060-1244
In Commercial Distribution

  • M697X06012441 ()

  • Length: 40 Millimeter
  • Width: 16 Millimeter


  • Lumbar interspinous decompression spacer, non-sterile
Axle Insert, Titanium, 14mm
Xtant Medical Holdings, Inc.
X060-0276
In Commercial Distribution

  • M697X06002761 ()

  • Length: 37 Millimeter
  • Width: 16 Millimeter


  • Lumbar interspinous decompression spacer, non-sterile
Axle Insert, PEEK, 16mm
Xtant Medical Holdings, Inc.
X060-0258
In Commercial Distribution

  • M697X06002581 ()

  • Length: 36 Millimeter
  • Width: 16 Millimeter


  • Lumbar interspinous decompression spacer, non-sterile
Axle Locking Plate Assy, 40, 16mm
Xtant Medical Holdings, Inc.
X060-0218
In Commercial Distribution

  • M697X06002181 ()

  • Length: 40 Millimeter
  • Width: 16 Millimeter


  • Lumbar interspinous decompression spacer, non-sterile
SST
Innovasis, Inc.
LS-458-08
In Commercial Distribution

  • M711LS458080 ()

  • Length: 14 Millimeter
  • Width: 16 Millimeter
  • Height: 10 Millimeter
  • Angle: 8 degree
LS-458-08

  • Bone file/rasp, manual, reusable
SST
Innovasis, Inc.
LS-458-07
In Commercial Distribution

  • M711LS458070 ()

  • Length: 14 Millimeter
  • Width: 16 Millimeter
  • Height: 6 Millimeter
  • Angle: 8 degree
LS-458-07

  • Bone file/rasp, manual, reusable
SST
Innovasis, Inc.
LS-457-04
In Commercial Distribution

  • M711LS457040 ()

  • Length: 14 Millimeter
  • Width: 16 Millimeter
  • Height: 12 Millimeter
  • Angle: 8 degree
LS-457-04

  • Spinal implant trial
TRIAL, 14L x 16W x 11-12H x 8°
Innovasis, Inc.
LS-456-12
In Commercial Distribution

  • M711LS456120 ()

  • Length: 14 Millimeter
  • Width: 16 Millimeter
  • Height: 12 Millimeter
  • Height: 11 Millimeter
  • Angle: 8 degree
LS-456-12

  • Spinal implant trial
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