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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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Irix-C Cervical Integrated Fusion System - M697X06600061

STERILIZATION CASE, ADDITIONAL INSTRUMENTS, IRIX-C
Xtant Medical Holdings, Inc.
X066-0006
In Commercial Distribution

  • M697X06600060 ()
  • M697X06600061 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697X06600041

Instrument Sterilization Case, Irix-C
Xtant Medical Holdings, Inc.
X066-0004
In Commercial Distribution

  • M697X06600040 ()
  • M697X06600041 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697X06600031

Implant Sterilization Case, Irix-C
Xtant Medical Holdings, Inc.
X066-0003
In Commercial Distribution

  • M697X06600030 ()
  • M697X06600031 ()


  • Polymeric spinal interbody fusion cage

Fixcet Spinal Facet Screw System - M697X06310001

Fixcet Spinal Facet Screw Set II
Xtant Medical Holdings, Inc.
X063-1000
In Commercial Distribution

  • M697X06310000 ()
  • M697X06310001 ()


  • Trans-facet-screw internal spinal fixation system, sterile

Fixcet Spinal Facet Screw System - M697X06300731

K-Wire, .054 Blunt End, 500mm
Xtant Medical Holdings, Inc.
X063-0073
In Commercial Distribution

  • M697X06300730 ()
  • M697X06300731 ()

  • Length: 500 Millimeter
  • Outer Diameter: 0.054 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable

Fixcet Spinal Facet Screw System - M697X06300721

K-Wire, .054 Blunt End, 350mm
Xtant Medical Holdings, Inc.
X063-0072
In Commercial Distribution

  • M697X06300720 ()
  • M697X06300721 ()

  • Length: 350 Millimeter
  • Outer Diameter: 0.054 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable

Fixcet Spinal Facet Screw System - M697X06300711

K-Wire, .054 Blunt End, 300mm
Xtant Medical Holdings, Inc.
X063-0071
In Commercial Distribution

  • M697X06300710 ()
  • M697X06300711 ()

  • Length: 300 Millimeter
  • Outer Diameter: 0.054 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable

Fixcet Spinal Facet Screw System - M697X06300701

K-Wire, .054 Blunt End, 250mm
Xtant Medical Holdings, Inc.
X063-0070
In Commercial Distribution

  • M697X06300700 ()
  • M697X06300701 ()

  • Length: 250 Millimeter
  • Outer Diameter: 0.054 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable

Fixcet Spinal Facet Screw System - M697X06300611

K-Wire, .054 Trocar End, 300mm
Xtant Medical Holdings, Inc.
X063-0061
In Commercial Distribution

  • M697X06300610 ()
  • M697X06300611 ()

  • Outer Diameter: 0.054 Millimeter
  • Length: 300 Millimeter


  • Orthopaedic bone pin, non-bioabsorbable

Calix Spinal Implant System - M697X03428901

26mm x 10mm x 16mm PLIF RASP ASSY
Xtant Medical Holdings, Inc.
X034-2890
In Commercial Distribution

  • M697X03428900 ()
  • M697X03428901 ()

  • Height: 16 Millimeter
  • Length: 26 Millimeter
  • Width: 10 Millimeter


  • Polymeric spinal interbody fusion cage
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