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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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CODA™ Anterior Cervical Plate System - 00840298700639

Awl
Pioneer Surgical Technology, Inc.
58-202220400
In Commercial Distribution

  • 00840298700639 ()

  • Length: 12 Millimeter
2022-20-400

  • Bone awl, reusable

Certex Spinal Fixation System - M697X06705501

PEDICLE PROBE, STRAIGHT LENKE
Xtant Medical Holdings, Inc.
X067-0550
Not in Commercial Distribution

  • M697X06705500 ()
  • M697X06705501 ()


  • Bone awl, reusable

OIC Intramedullary Nail System - M69601IM010

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

  • M69601IM010 ()


  • Bone awl, reusable

OIC Pedicle Screw System - M69633710200

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

  • M69633710200 ()


  • Bone awl, reusable

Genie RCR Instruments - 08809595975616

Ø5.5 Reusable AWL
OSTEONIC CO.,Ltd.
BMA-5519-AWL
In Commercial Distribution

  • 08809595975616 ()


  • 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
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