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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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Genie RCR Instruments - 08809399748546

Ø5.25 Reusable AWL(Healmax)
OSTEONIC CO.,Ltd.
BHA-5320-AWL
In Commercial Distribution

  • 08809399748546 ()


  • Bone awl, reusable

OIC Pedicle Screw System - M69633710200

BONE AWL
ORTHOPAEDIC IMPLANT COMPANY, THE
3371020
Not in Commercial Distribution

  • M69633710200 ()


  • Bone awl, reusable

OIC Intramedullary Nail System - M69601IM010

T-HANDLE AWL
ORTHOPAEDIC IMPLANT COMPANY, THE
01-IM01
In Commercial Distribution

  • M69601IM010 ()


  • Bone awl, reusable

Fortex Pedicle Screw System - M697C01000881

Special Instrument Straight Lenke Probe
Xtant Medical Holdings, Inc.
C010-0088
In Commercial Distribution

  • M697C01000880 ()
  • M697C01000881 ()


  • Bone awl, reusable

Fortex Pedicle Screw System - M697C01000801

Specialty Lenke-style Pedical Probe Fortex
Xtant Medical Holdings, Inc.
C010-0080
In Commercial Distribution

  • M697C01000800 ()
  • M697C01000801 ()


  • Bone awl, reusable

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
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