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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SCREWDRIVER SHAFT ASSY, LONG
Xtant Medical Holdings, Inc.
T076-0063
In Commercial Distribution

  • M697T07600630 ()
  • M697T07600631 ()


  • Surgical screwdriver, reusable
Screw Driver
Zavation LLC
290-1011
In Commercial Distribution

  • 00842166180758 ()


  • Orthopaedic implant driver
Driver Sleeve
Zavation LLC
290-1010
In Commercial Distribution

  • 00842166180741 ()


  • Orthopaedic implantation sleeve, reusable
MALLET, ASSY
Xtant Medical Holdings, Inc.
X063-0055
In Commercial Distribution

  • M697X06300550 ()
  • M697X06300551 ()


  • Surgical mallet
FIXCET SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
X063-0025
In Commercial Distribution

  • M697X06300250 ()
  • M697X06300251 ()


  • Surgical screwdriver, reusable
In-Situ Driver
NEXXT SPINE, LLC
I14-02-01
In Commercial Distribution

  • 00889929011478 ()


  • General internal orthopaedic fixation system implantation kit
Implant Driver
Wenzel Spine, Inc.
800-1211
In Commercial Distribution

  • 00813210022010 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Removal Driver
Wenzel Spine, Inc.
800-1203
In Commercial Distribution

  • 00813210022003 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
FS3 Stab-N-Grab Driver, T20
Life Spine, Inc.
2017-0121
In Commercial Distribution

  • 00190837041496 ()
2017-0121

  • Bone-screw internal spinal fixation system, non-sterile
Facet Screw Driver, Mid Length with Flats
Life Spine, Inc.
2017-0090
In Commercial Distribution

  • 00190837041489 ()
2017-0090

  • Bone-screw internal spinal fixation system, non-sterile
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