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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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CAM SCREWDRIVER HEX SHAFT
Xtant Medical Holdings, Inc.
N60001576
In Commercial Distribution

  • M697N600015760 ()
  • M697N600015761 ()


  • Surgical screwdriver, reusable
FINAL LOCKING WRENCH, 1/4" SQUARE
Xtant Medical Holdings, Inc.
N60001554
In Commercial Distribution

  • M697N600015540 ()
  • M697N600015541 ()


  • Surgical screwdriver, reusable
Adjustment Screwdriver
Xtant Medical Holdings, Inc.
N60001552
In Commercial Distribution

  • M697N600015520 ()
  • M697N600015521 ()


  • Surgical screwdriver, reusable
AO Hex Driver
Xtant Medical Holdings, Inc.
N60000927
In Commercial Distribution

  • M697N600009270 ()
  • M697N600009271 ()


  • Spinal fixation plate, non-bioabsorbable
AO Hex Driver Assy
Xtant Medical Holdings, Inc.
N60000926
In Commercial Distribution

  • M697N600009260 ()
  • M697N600009261 ()


  • Spinal fixation plate, non-bioabsorbable
Capless Screw System Driver Assembly
Xtant Medical Holdings, Inc.
N60000771
In Commercial Distribution

  • M697N600007710 ()
  • M697N600007711 ()


  • Surgical screwdriver, reusable
Specialty Guided Universal Joint Hex Driver
Xtant Medical Holdings, Inc.
C080-0106
In Commercial Distribution

  • M697C08001060 ()
  • M697C08001061 ()


  • Polymeric spinal interbody fusion cage
Specialty Universal Joint Driver Assy
Xtant Medical Holdings, Inc.
C080-0104
In Commercial Distribution

  • M697C08001040 ()
  • M697C08001041 ()


  • Polymeric spinal interbody fusion cage
Irix-A Specialty Irix-A Driver
Xtant Medical Holdings, Inc.
C080-0039
In Commercial Distribution

  • M697C08000390 ()
  • M697C08000391 ()


  • Surgical screwdriver, reusable
CUSTOM IMPACTION DRIVER
Xtant Medical Holdings, Inc.
C079-0026
In Commercial Distribution

  • M697C07900260 ()
  • M697C07900261 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implant, coated
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