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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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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

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

Brickyard Stand-Alone ALIF - 00843210184166

U-Joint Awl with Sleeve, 15mm
Altus Spine, LLC
1030-2615A
In Commercial Distribution

  • 00843210184166 ()


  • Bone awl, reusable

Brickyard Stand-Alone ALIF - 00843210183893

U-Joint Awl, 40mm
Altus Spine, LLC
1030-2140A
In Commercial Distribution

  • 00843210183893 ()


  • Bone awl, reusable

Brickyard Stand-Alone ALIF - 00843210182063

U-Joint Awl, 35mm
Altus Spine, LLC
1030-2135A
In Commercial Distribution

  • 00843210182063 ()


  • Bone awl, reusable

Brickyard Stand-Alone ALIF - 00843210182056

U-Joint Awl, 30mm
Altus Spine, LLC
1030-2130A
In Commercial Distribution

  • 00843210182056 ()


  • Bone awl, reusable

Brickyard Stand-Alone ALIF - 00843210182049

U-Joint Awl, 25mm
Altus Spine, LLC
1030-2125A
In Commercial Distribution

  • 00843210182049 ()


  • Bone awl, reusable
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