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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 - M697X06700351

CERTEX 3.5 X 40mm SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0035
In Commercial Distribution

  • M697X06700351 ()

  • Length: 40 Millimeter
  • Outer Diameter: 3.5 Millimeter


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

Irix-C Cervical Integrated Fusion System - M697X066181406P1

IRIX-C INTEGRATED SPACER ASSY, 18 X 14 X 0°, 6mm
Xtant Medical Holdings, Inc.
X066-181406P
In Commercial Distribution

  • M697X066181406P1 ()

  • Width: 18 Millimeter
  • Angle 0 Degree
  • Height: 6 Millimeter
  • Length: 14 Millimeter


  • Polymeric spinal interbody fusion cage

OIC Cannulated Screw System - M6964012040S0

CANNULATED SCREW 4.0MM X 40MM LONG THREAD
ORTHOPAEDIC IMPLANT COMPANY, THE
40-12040S
In Commercial Distribution

  • M6964012040S0 ()

  • Outer Diameter: 4.0 Millimeter
  • Length: 40 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, non-sterile

Certex Spinal Fixation System - M697X0671602LM1

3.5mm DIA X 40mm CONTINUOUS RADIUS ROD WITH LINE
Xtant Medical Holdings, Inc.
X067-1602LM
In Commercial Distribution

  • M697X0671602LM1 ()

  • Length: 40 Millimeter
  • Outer Diameter: 3.5 Millimeter


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

Certex Spinal Fixation System - M697X06715151

CERTEX 4.0 X 40mm SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-1515
In Commercial Distribution

  • M697X06715151 ()

  • Length: 40 Millimeter
  • Outer Diameter: 4 Millimeter


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

Certex Spinal Fixation System - M697X06702661

CERTEX 3.5 X 24mm THREADED X 16mm SMOOTH X 40mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0266
In Commercial Distribution

  • M697X06702661 ()

  • Length: 16 Millimeter
  • Outer Diameter: 3.5 Millimeter
  • Length: 24 Millimeter
  • Length: 40 Millimeter


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

Irix-C Cervical Integrated Fusion System - M697X066181406TPPC1

IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 6mm, PC
Xtant Medical Holdings, Inc.
X066-181406TP-PC
In Commercial Distribution

  • M697X066181406TPPC1 ()

  • Width: 18 Millimeter
  • Height: 6 Millimeter
  • Angle 0 Degree
  • Length: 14 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697X066181406TP1

IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 0°, 6mm
Xtant Medical Holdings, Inc.
X066-181406TP
In Commercial Distribution

  • M697X066181406TP1 ()

  • Angle 0 Degree
  • Length: 14 Millimeter
  • Width: 18 Millimeter
  • Height: 6 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697X066181406TLPC1

IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 6mm, PC
Xtant Medical Holdings, Inc.
X066-181406TL-PC
In Commercial Distribution

  • M697X066181406TLPC1 ()

  • Height: 6 Millimeter
  • Width: 18 Millimeter
  • Length: 14 Millimeter
  • Angle: 7 degree


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697X066181406TL1

IRIX-C INTEGRATED SPACER, TITANIUM, 18 X 14 X 7°, 6mm
Xtant Medical Holdings, Inc.
X066-181406TL
In Commercial Distribution

  • M697X066181406TL1 ()

  • Angle: 7 degree
  • Height: 6 Millimeter
  • Length: 14 Millimeter
  • Width: 18 Millimeter


  • Polymeric spinal interbody fusion cage
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