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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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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

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

Fortex Pedicle Screw System - M697C01000391

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

  • M697C01000390 ()
  • M697C01000391 ()


  • 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

Q Pedicle Instruments - 10888857553033

Q Awl
K2M, INC.
48111003
In Commercial Distribution

  • 10888857553033 ()
48111003

  • Bone awl, reusable

CANNULATED CURVED AWL, T-HANDLE - 00848665001242

No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0256-000
In Commercial Distribution

  • 00848665001242 ()


  • Bone awl, reusable

Fuji Cervical Plate System - 00843210133218

SSP: Trocar Awl 2.5mm
Altus Spine, LLC
100-1018
In Commercial Distribution

  • 00843210133218 ()


  • Bone awl, reusable

Valencia Pedicle Screw System - 00843210134222

PSS: Awl
Altus Spine, LLC
900-1000
In Commercial Distribution

  • 00843210134222 ()


  • Bone awl, reusable

Brickyard Stand-Alone ALIF - 00843210180304

45° Geared Awl Tip
Altus Spine, LLC
1030-0100G-45
In Commercial Distribution

  • 00843210180304 ()


  • Bone awl, reusable
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