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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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Fortex Pedicle Screw System - M697C01000691

4.75mm SPECIALTY FORTEX TAP MODIFIED NECK
Xtant Medical Holdings, Inc.
C010-0069
In Commercial Distribution

  • M697C01000690 ()
  • M697C01000691 ()


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697C01000681

Specialty Bone Awl
Xtant Medical Holdings, Inc.
C010-0068
In Commercial Distribution

  • M697C01000680 ()
  • M697C01000681 ()


  • Bone-screw internal spinal fixation system, non-sterile

Fortex Pedicle Screw System - M697C01000391

SPECIALTY STRAIGHT LENKE PROBE
Xtant Medical Holdings, Inc.
C010-0039
In Commercial Distribution

  • M697C01000390 ()
  • M697C01000391 ()


  • Bone-screw internal spinal fixation system, non-sterile

Xpress Minimally Invasive Pedicle Screw System - M697C010000871

Tall Anti-Splay Ring
Xtant Medical Holdings, Inc.
C064-0001
In Commercial Distribution

  • M697C01000870 ()
  • M697C010000871 ()


  • Bone-screw internal spinal fixation system, non-sterile

Calix-C Cervical Interbody Spacer - M697C00300601

SPECIAL LORDOTIC RASP, 11mm x 14mm x 7mm
Xtant Medical Holdings, Inc.
C003-0060
In Commercial Distribution

  • M697C00300600 ()
  • M697C00300601 ()

  • Angle: 7 degree
  • Height: 7 Millimeter


  • Polymeric spinal interbody fusion cage

Calix-C Cervical Interbody Spacer - M697C00300591

SPECIAL LORDOTIC RASP, 11mm x 14mm x 6mm
Xtant Medical Holdings, Inc.
C003-0059
In Commercial Distribution

  • M697C00300590 ()
  • M697C00300591 ()

  • Angle: 7 degree
  • Height: 6 Millimeter


  • Polymeric spinal interbody fusion cage

Calix-C Cervical Interbody Spacer - M697C00300581

SPECIAL LORDOTIC RASP, 11mm x 14mm x 5mm
Xtant Medical Holdings, Inc.
C003-0058
In Commercial Distribution

  • M697C00300580 ()
  • M697C00300581 ()

  • Height: 5 Millimeter
  • Angle: 7 degree


  • Polymeric spinal interbody fusion cage

Calix-C Cervical Interbody Spacer - M697C00300571

Special 13mm x 16mm Lordotic Rasp, 12mm
Xtant Medical Holdings, Inc.
C003-0057
In Commercial Distribution

  • M697C00300570 ()
  • M697C00300571 ()

  • Width: 16 Millimeter
  • Length: 13 Millimeter
  • Height: 12 Millimeter
  • Angle: 7 degree


  • Polymeric spinal interbody fusion cage

Calix-C Cervical Interbody Spacer - M697C00300561

Special 13mm x 16mm Lordotic Rasp, 11mm
Xtant Medical Holdings, Inc.
C003-0056
In Commercial Distribution

  • M697C00300560 ()
  • M697C00300561 ()

  • Width: 16 Millimeter
  • Length: 13 Millimeter
  • Height: 11 Millimeter
  • Angle: 7 degree


  • Polymeric spinal interbody fusion cage

Calix-C Cervical Interbody Spacer - M697C00300551

Special 13mm x 16mm Lordotic Rasp, 10mm
Xtant Medical Holdings, Inc.
C003-0055
In Commercial Distribution

  • M697C00300550 ()
  • M697C00300551 ()

  • Width: 16 Millimeter
  • Length: 13 Millimeter
  • Height: 10 Millimeter
  • Angle: 7 degree


  • Polymeric spinal interbody fusion cage
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