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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 - M697C08000391

Irix-A Specialty Irix-A Driver
Xtant Medical Holdings, Inc.
C080-0039
In Commercial Distribution

  • M697C08000390 ()
  • M697C08000391 ()


  • Surgical screwdriver, reusable

Xpress Minimally Invasive Pedicle Screw System - M697C07300721

SPECIALTY XPRESS DRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C073-0072
In Commercial Distribution

  • M697C07300720 ()
  • M697C07300721 ()


  • Surgical screwdriver, reusable

Xpress Minimally Invasive Pedicle Screw System - M697C07300711

SPECIALTY XPRESS SHORTENED PEDICLE SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C073-0071
In Commercial Distribution

  • M697C07300710 ()
  • M697C07300711 ()


  • Surgical screwdriver, reusable

Xpress Minimally Invasive Pedicle Screw System - M697C07300691

SPECIALTY XPRESS SHORTENED PEDICLE SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C073-0069
In Commercial Distribution

  • M697C07300690 ()
  • M697C07300691 ()


  • Surgical screwdriver, reusable

Xpress Minimally Invasive Pedicle Screw System - M697C07300591

SPECIALTY XPRESS NAVIGATION DRIVER
Xtant Medical Holdings, Inc.
C073-0059
In Commercial Distribution

  • M697C07300590 ()
  • M697C07300591 ()


  • Surgical screwdriver, reusable

Xpress Minimally Invasive Pedicle Screw System - M697C07300531

SPECIALTY XPRESS PEDICLE SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C073-0053
In Commercial Distribution

  • M697C07300530 ()
  • M697C07300531 ()


  • Surgical screwdriver, reusable

Xpress Minimally Invasive Pedicle Screw System - M697C07300421

Xpress Specialty Cap Introducer
Xtant Medical Holdings, Inc.
C073-0042
In Commercial Distribution

  • M697C07300420 ()
  • M697C07300421 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697C06700511

SPECIAL INSTRUMENT CERTEX, SCREWDRIVER ASSEMBLY X067-0440 MODIFIED
Xtant Medical Holdings, Inc.
C067-0051
Not in Commercial Distribution

  • M697C06700510 ()
  • M697C06700511 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697C06700491

Extended Cap Driver
Xtant Medical Holdings, Inc.
C067-0049
Not in Commercial Distribution

  • M697C06700490 ()
  • M697C06700491 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697C06700421

Specialty Certex Pedicle Screwdriver
Xtant Medical Holdings, Inc.
C067-0042
Not in Commercial Distribution

  • M697C06700420 ()
  • M697C06700421 ()


  • Surgical screwdriver, reusable
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