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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-A Lumbar Integrated Fusion System - M697T08000331

Irix A Mallet/Extractor
Xtant Medical Holdings, Inc.
T080-0033
In Commercial Distribution

  • M697T08000330 ()
  • M697T08000331 ()


  • Surgical mallet

Irix-A Lumbar Integrated Fusion System - M697T08000301

Irix A Mallet/Extractor
Xtant Medical Holdings, Inc.
T080-0030
In Commercial Distribution

  • M697T08000300 ()
  • M697T08000301 ()


  • Surgical mallet

Zyfix Spinal Facet Screw System - M697T07600641

SCREWDRIVER SHAFT ASSY, SHORT
Xtant Medical Holdings, Inc.
T076-0064
In Commercial Distribution

  • M697T07600640 ()
  • M697T07600641 ()


  • Surgical screwdriver, reusable

Zyfix Spinal Facet Screw System - M697T07600631

SCREWDRIVER SHAFT ASSY, LONG
Xtant Medical Holdings, Inc.
T076-0063
In Commercial Distribution

  • M697T07600630 ()
  • M697T07600631 ()


  • Surgical screwdriver, reusable

Xpress Minimally Invasive Pedicle Screw System - M697T07313101

FINAL CAP DRIVER
Xtant Medical Holdings, Inc.
T073-1310
In Commercial Distribution

  • M697T07313100 ()
  • M697T07313101 ()


  • Surgical screwdriver, reusable

Xpress Minimally Invasive Pedicle Screw System - M697T07307001

PEDICLE SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
T073-0700
In Commercial Distribution

  • M697T07307000 ()
  • M697T07307001 ()


  • Surgical screwdriver, reusable

Irix-C Cervical Integrated Fusion System - M697T06600781

Assembly, Fixed Angle Driver Tip
Xtant Medical Holdings, Inc.
T066-0078
In Commercial Distribution

  • M697T06600780 ()
  • M697T06600781 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697T06600741

Assembly, Straight Driver
Xtant Medical Holdings, Inc.
T066-0074
In Commercial Distribution

  • M697T06600740 ()
  • M697T06600741 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697T06600681

Shaft Assembly, Fixed Angle Driver
Xtant Medical Holdings, Inc.
T066-0068
In Commercial Distribution

  • M697T06600680 ()
  • M697T06600681 ()


  • Polymeric spinal interbody fusion cage

Irix-C Cervical Integrated Fusion System - M697T06600631

Angled Sleeve, Fixed-Angle Driver
Xtant Medical Holdings, Inc.
T066-0063
In Commercial Distribution

  • M697T06600630 ()
  • M697T06600631 ()


  • Polymeric spinal interbody fusion cage
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