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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 - 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

X90 Pedicle Screw System - M697CN60002191

Specialty X-90 Reducer Wrench Assembly
Xtant Medical Holdings, Inc.
CN60-0021-9
In Commercial Distribution

  • M697CN60002190 ()
  • M697CN60002191 ()


  • 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 - 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 - M697C08000801

IRIX A UNIVERSAL JOINT GUIDED HEX DRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0080
In Commercial Distribution

  • M697C08000800 ()
  • M697C08000801 ()


  • 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

Silex Sacroiliac Joint Fusion System - M697C07900261

CUSTOM IMPACTION DRIVER
Xtant Medical Holdings, Inc.
C079-0026
In Commercial Distribution

  • M697C07900260 ()
  • M697C07900261 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated

Silex Sacroiliac Joint Fusion System - M697C07900111

SPECIALTY 12.5 mm IMPLANT DRIVER
Xtant Medical Holdings, Inc.
C079-0011
In Commercial Distribution

  • M697C07900110 ()
  • M697C07900111 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

Xpress Minimally Invasive Pedicle Screw System - M697C07300901

Specialty Xpress Cannulated Final Locking Cap Driver
Xtant Medical Holdings, Inc.
C073-0090
In Commercial Distribution

  • M697C07300900 ()
  • M697C07300901 ()


  • Surgical screwdriver, reusable
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