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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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Pedicle Screwdriver Assembly, Fortex, Wing Lock
Xtant Medical Holdings, Inc.
X022-0240
In Commercial Distribution

  • M697X02202400 ()
  • M697X02202401 ()


  • Surgical screwdriver, reusable
Fast Drive Adapter, 1/4 in Square
Xtant Medical Holdings, Inc.
X022-0165
In Commercial Distribution

  • M697X02201650 ()
  • M697X02201651 ()


  • Surgical screwdriver, reusable
Final Locking Sleeve Assembly
Xtant Medical Holdings, Inc.
X022-0162
In Commercial Distribution

  • M697X02201620 ()
  • M697X02201621 ()


  • Surgical screwdriver, reusable
Final Locking Cap Driver Assembly
Xtant Medical Holdings, Inc.
X022-0161
In Commercial Distribution

  • M697X02201610 ()
  • M697X02201611 ()


  • Surgical screwdriver, reusable
Pedicle Screwdriver Assembly
Xtant Medical Holdings, Inc.
X022-0140
In Commercial Distribution

  • M697X02201400 ()
  • M697X02201401 ()


  • Surgical screwdriver, reusable
Fortex Adjustment Screwdriver
Xtant Medical Holdings, Inc.
X022-0139
In Commercial Distribution

  • M697X02201390 ()
  • M697X02201391 ()


  • Surgical screwdriver, reusable
Pedicle Screw Head Turner
Xtant Medical Holdings, Inc.
X022-0136
In Commercial Distribution

  • M697X02201360 ()
  • M697X02201361 ()


  • Surgical screwdriver, reusable
Fortex Long Cap Introducer Assembly
Xtant Medical Holdings, Inc.
X022-0134
In Commercial Distribution

  • M697X02201340 ()
  • M697X02201341 ()


  • Surgical screwdriver, reusable
Cap Introducer Assembly
Xtant Medical Holdings, Inc.
X022-0130
In Commercial Distribution

  • M697X02201300 ()
  • M697X02201301 ()


  • Surgical screwdriver, reusable
Irix A Screw Remover
Xtant Medical Holdings, Inc.
T080-0080
In Commercial Distribution

  • M697T08000800 ()
  • M697T08000801 ()


  • Surgical screwdriver, reusable
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