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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 - M697T08000561

Irix A Self-Centering Awl
Xtant Medical Holdings, Inc.
T080-0056
In Commercial Distribution

  • M697T08000560 ()
  • M697T08000561 ()


  • Bone awl, reusable

Irix-A Lumbar Integrated Fusion System - M697T08000551

Irix A Universal Joint Awl
Xtant Medical Holdings, Inc.
T080-0055
In Commercial Distribution

  • M697T08000550 ()
  • M697T08000551 ()


  • Bone awl, reusable

Irix-A Lumbar Integrated Fusion System - M697C08001021

Specialty Irix A Fixed Angle Guided AWL Assembly
Xtant Medical Holdings, Inc.
C080-0102
In Commercial Distribution

  • M697C08001020 ()
  • M697C08001021 ()


  • Bone awl, reusable

Irix-A Lumbar Integrated Fusion System - M697C08000701

SPECIALTY UNIVERSAL JOINT AWL (STIFFER JOINT)
Xtant Medical Holdings, Inc.
C080-0070
In Commercial Distribution

  • M697C08000700 ()
  • M697C08000701 ()


  • Bone awl, reusable

Certex Spinal Fixation System - M697C06700401

SPECIALTY CERTEX CURVED LENKE PROBE
Xtant Medical Holdings, Inc.
C067-0040
Not in Commercial Distribution

  • M697C06700400 ()
  • M697C06700401 ()


  • Bone awl, reusable

Irix-C Cervical Integrated Fusion system - M697C06601211

60 Degree Fixed Angle Awl
Xtant Medical Holdings, Inc.
C066-0121
In Commercial Distribution

  • M697C06601210 ()
  • M697C06601211 ()


  • Bone awl, reusable

Irix-C Cervical Integrated Fusion system - M697C06601191

Specialty Self Centering Bent Awl
Xtant Medical Holdings, Inc.
C066-0119
In Commercial Distribution

  • M697C06601190 ()
  • M697C06601191 ()


  • Bone awl, reusable

Fortex Pedicle Screw System - M697C01000391

SPECIALTY STRAIGHT LENKE PROBE
Xtant Medical Holdings, Inc.
C010-0039
In Commercial Distribution

  • M697C01000390 ()
  • M697C01000391 ()


  • Bone awl, reusable

Kestrel® - M711LS4350

SST
Innovasis, Inc.
LS-435
In Commercial Distribution

  • M711LS4350 ()
LS-435

  • Bone awl, reusable

Excella II® - M711LS2200

Awl, Cannulated, Palm Handle, Al, Silicone, SST
Innovasis, Inc.
LS-220
In Commercial Distribution

  • M711LS2200 ()


  • Bone awl, reusable
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