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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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Certex Spinal Fixation System - M697X06700031

Sterilization Case, Certex, Implant
Xtant Medical Holdings, Inc.
X067-0003
In Commercial Distribution

  • M697X06700030 ()
  • M697X06700031 ()


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

Irix-C Cervical Integrated Fusion System - M697X0660252PCCS1

16 x 13 Parallel Caddy Set, Titanium, PC, Irix-C
Xtant Medical Holdings, Inc.
X066-0252PC-CS
In Commercial Distribution

  • M697X0660252PCCS0 ()
  • M697X0660252PCCS1 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697X0660252PC1

16 x 13 Parallel Caddy, Titanium, PC, Irix-C
Xtant Medical Holdings, Inc.
X066-0252PC
In Commercial Distribution

  • M697X0660252PC0 ()
  • M697X0660252PC1 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697X0660251PCCS1

18 x 14 Lordotic Caddy Set, Titanium, PC, Irix-C
Xtant Medical Holdings, Inc.
X066-0251PC-CS
In Commercial Distribution

  • M697X0660251PCCS0 ()
  • M697X0660251PCCS1 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697X0660251PC1

18 x 14 Lordotic Caddy, Titanium, PC, Irix-C
Xtant Medical Holdings, Inc.
X066-0251PC
In Commercial Distribution

  • M697X0660251PC0 ()
  • M697X0660251PC1 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697X0660250PCCS1

16 x 13 Lordotic Caddy Set, Titanium, PC, Irix-C
Xtant Medical Holdings, Inc.
X066-0250PC-CS
In Commercial Distribution

  • M697X0660250PCCS0 ()
  • M697X0660250PCCS1 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697X0660250PC1

16 x 13 Lordotic Caddy, Titanium, PC, Irix-C
Xtant Medical Holdings, Inc.
X066-0250PC
In Commercial Distribution

  • M697X0660250PC0 ()
  • M697X0660250PC1 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697X06602421

Modular Inserter Tip Caddy, Irix-C
Xtant Medical Holdings, Inc.
X066-0242
In Commercial Distribution

  • M697X06602420 ()
  • M697X06602421 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697X06602411

Fixed Angle Tip Caddy, Irix-C
Xtant Medical Holdings, Inc.
X066-0241
In Commercial Distribution

  • M697X06602410 ()
  • M697X06602411 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697X06602401

Screw Caddy, Irix-C
Xtant Medical Holdings, Inc.
X066-0240
In Commercial Distribution

  • M697X06602400 ()
  • M697X06602401 ()


  • Polymeric spinal interbody fusion cage
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