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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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X90 Pedicle Screw System - M697N600015751

CAM SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
N60001575
In Commercial Distribution

  • M697N600015750 ()
  • M697N600015751 ()


  • Surgical screwdriver, reusable

X90 Pedicle Screw System - M697N600004901

Pre-Locking Wrench Assembly
Xtant Medical Holdings, Inc.
N60000490
In Commercial Distribution

  • M697N600004900 ()
  • M697N600004901 ()


  • Surgical screwdriver, reusable

X90 Pedicle Screw System - M697N600004751

Screwdriver Assembly
Xtant Medical Holdings, Inc.
N60000475
In Commercial Distribution

  • M697N600004750 ()
  • M697N600004751 ()


  • Surgical screwdriver, reusable

X90 Pedicle Screw System - M697CN6000261

Specialty Locking Pedicle Screwdriver
Xtant Medical Holdings, Inc.
CN60-0026
In Commercial Distribution

  • M697CN6000260 ()
  • M697CN6000261 ()


  • Surgical screwdriver, reusable

Irix-A Lumbar Integrated Fusion System - M697C08001081

Irix-A Smooth shaft Universal Joint Driver
Xtant Medical Holdings, Inc.
C080-0108
In Commercial Distribution

  • M697C08001080 ()
  • M697C08001081 ()


  • Surgical screwdriver, reusable

Irix-A Lumbar Integrated Fusion System - M697C08001071

Irix-A Smooth Driver
Xtant Medical Holdings, Inc.
C080-0107
In Commercial Distribution

  • M697C08001070 ()
  • M697C08001071 ()


  • Surgical screwdriver, reusable

Irix-A Lumbar Integrated Fusion System - M697C08001061

Specialty Guided Universal Joint Hex Driver
Xtant Medical Holdings, Inc.
C080-0106
In Commercial Distribution

  • M697C08001060 ()
  • M697C08001061 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08001051

Specialty Unguided Universal Joint Hex Driver
Xtant Medical Holdings, Inc.
C080-0105
In Commercial Distribution

  • M697C08001050 ()
  • M697C08001051 ()


  • Polymeric spinal interbody fusion cage

Irix-A Lumbar Integrated Fusion System - M697C08001041

Specialty Universal Joint Driver Assy
Xtant Medical Holdings, Inc.
C080-0104
In Commercial Distribution

  • M697C08001040 ()
  • M697C08001041 ()


  • Polymeric spinal interbody fusion cage

Silex Sacroiliac Joint Fusion System - M697C07902641

SPECIAL 7mm ADJUSTMENT IMPLANT DRIVER, CANNULATED
Xtant Medical Holdings, Inc.
C079-0264
In Commercial Distribution

  • M697C07902640 ()
  • M697C07902641 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
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