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 Class Implantable

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Assembly, Fortex, 7.5 x 40 Reduction Screw
Xtant Medical Holdings, Inc.
X064-0021
In Commercial Distribution

  • M697X06400211 ()

  • Length: 40 Millimeter
  • Outer Diameter: 7.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 6.5 x 40 Reduction, Dual Lead, Screw
Xtant Medical Holdings, Inc.
X064-0015-DL
In Commercial Distribution

  • M697X0640015DL1 ()

  • Length: 40 Millimeter
  • Outer Diameter: 6.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 6.5 x 40 Reduction Screw
Xtant Medical Holdings, Inc.
X064-0015
In Commercial Distribution

  • M697X06400151 ()

  • Outer Diameter: 6.5 Millimeter
  • Length: 40 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 5.5 x 40 Reduction, Dual Lead, Screw
Xtant Medical Holdings, Inc.
X064-0009-DL
In Commercial Distribution

  • M697X0640009DL1 ()

  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 5.5 x 40 Reduction Screw
Xtant Medical Holdings, Inc.
X064-0009
In Commercial Distribution

  • M697X06400091 ()

  • Length: 40 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 4.75 x 40 Reduction, Dual Lead, Screw
Xtant Medical Holdings, Inc.
X064-0003-DL
In Commercial Distribution

  • M697X0640003DL1 ()

  • Length: 40 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Assembly, Fortex, 4.75 x 40 Reduction Screw
Xtant Medical Holdings, Inc.
X064-0003
In Commercial Distribution

  • M697X06400031 ()

  • Length: 40 Millimeter
  • Outer Diameter: 4.75 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
AXLE-X LOCKING PLATE ASSEMBLY, 40MM, NO INSERT
Xtant Medical Holdings, Inc.
X060-1257
In Commercial Distribution

  • M697X06012571 ()

  • Length: 40 Millimeter


  • Lumbar interspinous decompression spacer, 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-X LOCKING PLATE ASSEMBLY, 40MM, 15MM
Xtant Medical Holdings, Inc.
X060-1243
In Commercial Distribution

  • M697X06012431 ()

  • Width: 15 Millimeter
  • Length: 40 Millimeter


  • Lumbar interspinous decompression spacer, non-sterile
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