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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 - M697T06601951

Mallet
Xtant Medical Holdings, Inc.
T066-0195
In Commercial Distribution

  • M697T06601950 ()
  • M697T06601951 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697T06601901

Tamp
Xtant Medical Holdings, Inc.
T066-0190
In Commercial Distribution

  • M697T06601900 ()
  • M697T06601901 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697T06601661

11/12mm Parallel Trial Assy, 16 X 13
Xtant Medical Holdings, Inc.
T066-0166
In Commercial Distribution

  • M697T06601660 ()
  • M697T06601661 ()

  • Height: 12 Millimeter
  • Height: 11 Millimeter
  • Width: 16 Millimeter
  • Length: 13 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697T06601641

9/10mm Parallel Trial Assy, 16 X 13
Xtant Medical Holdings, Inc.
T066-0164
In Commercial Distribution

  • M697T06601640 ()
  • M697T06601641 ()

  • Width: 16 Millimeter
  • Length: 13 Millimeter
  • Height: 10 Millimeter
  • Height: 9 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697T06601621

7/8mm Parallel Trial Assy, 16 X 13
Xtant Medical Holdings, Inc.
T066-0162
In Commercial Distribution

  • M697T06601620 ()
  • M697T06601621 ()

  • Height: 7 Millimeter
  • Height: 8 Millimeter
  • Length: 13 Millimeter
  • Width: 16 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697T06601201

5mm Lordotic Rasp Assy, 16 X 13
Xtant Medical Holdings, Inc.
T066-0120
In Commercial Distribution

  • M697T06601200 ()
  • M697T06601201 ()

  • Length: 13 Millimeter
  • Width: 16 Millimeter
  • Height: 5 Millimeter


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697T06601101

Straight Tap
Xtant Medical Holdings, Inc.
T066-0110
In Commercial Distribution

  • M697T06601100 ()
  • M697T06601101 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697T06601051

Fixed Angle Tap Tip
Xtant Medical Holdings, Inc.
T066-0105
In Commercial Distribution

  • M697T06601050 ()
  • M697T06601051 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697T06600981

Guide Handle Assembly
Xtant Medical Holdings, Inc.
T066-0098
In Commercial Distribution

  • M697T06600980 ()
  • M697T06600981 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697T06600941

20mm, Straight Drill
Xtant Medical Holdings, Inc.
T066-0094
In Commercial Distribution

  • M697T06600940 ()
  • M697T06600941 ()

  • Length: 20 Millimeter


  • Polymeric spinal interbody fusion cage
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