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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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Assy, Occipital Universal Joint Driver, Self-Retaining
Xtant Medical Holdings, Inc.
X067-1000
Not in Commercial Distribution

  • M697X06710000 ()
  • M697X06710001 ()


  • Surgical screwdriver, reusable
ASSY, HEX DRIVER GUIDE
Xtant Medical Holdings, Inc.
X067-0850
Not in Commercial Distribution

  • M697X06708500 ()
  • M697X06708501 ()


  • Orthopaedic implantation sleeve, reusable
TORQUE DRIVER T-HANDLE, 1/4" SQUARE CONNECT
Xtant Medical Holdings, Inc.
X067-0805
Not in Commercial Distribution

  • M697X06708050 ()
  • M697X06708051 ()


  • Surgical instrument handle, torque-limiting
TORQUE DRIVER HANDLE, 1/4" SQUARE CONNECT
Xtant Medical Holdings, Inc.
X067-0800
Not in Commercial Distribution

  • M697X06708000 ()
  • M697X06708001 ()


  • Surgical instrument handle, torque-limiting
SCREW HEAD TURNER
Xtant Medical Holdings, Inc.
X067-0630
Not in Commercial Distribution

  • M697X06706300 ()
  • M697X06706301 ()


  • Surgical screwdriver, reusable
ADJUSTMENT SCREWDRIVER
Xtant Medical Holdings, Inc.
X067-0600
Not in Commercial Distribution

  • M697X06706000 ()
  • M697X06706001 ()


  • Surgical screwdriver, reusable
ASSEMBLY, CAP DRIVER, SELF-RETAINING
Xtant Medical Holdings, Inc.
X067-0520
Not in Commercial Distribution

  • M697X06705200 ()
  • M697X06705201 ()


  • Surgical screwdriver, reusable
CERTEX SCREWDRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0440
Not in Commercial Distribution

  • M697X06704400 ()
  • M697X06704401 ()


  • Surgical screwdriver, reusable
CROSS CONNECTOR LOCKING DRIVER
Xtant Medical Holdings, Inc.
X067-0425
Not in Commercial Distribution

  • M697X06704250 ()
  • M697X06704251 ()


  • Surgical screwdriver, reusable
IRIX A UNIVERSAL JOINT GUIDED HEX DRIVER ASSEMBLY
Xtant Medical Holdings, Inc.
C080-0080
In Commercial Distribution

  • M697C08000800 ()
  • M697C08000801 ()


  • Polymeric spinal interbody fusion cage
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