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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 - M697X02201621

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

  • M697X02201620 ()
  • M697X02201621 ()


  • Surgical screwdriver, reusable

Fortex Pedicle Screw System - M697X02201611

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

  • M697X02201610 ()
  • M697X02201611 ()


  • Surgical screwdriver, reusable

Fortex Pedicle Screw System - M697X02201401

Pedicle Screwdriver Assembly
Xtant Medical Holdings, Inc.
X022-0140
In Commercial Distribution

  • M697X02201400 ()
  • M697X02201401 ()


  • Surgical screwdriver, reusable

Fortex Pedicle Screw System - M697X02201361

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

  • M697X02201360 ()
  • M697X02201361 ()


  • Surgical screwdriver, reusable

Fortex Pedicle Screw System - M697X02201341

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

  • M697X02201340 ()
  • M697X02201341 ()


  • Surgical screwdriver, reusable

Fortex Pedicle Screw System - M697X02201301

Cap Introducer Assembly
Xtant Medical Holdings, Inc.
X022-0130
In Commercial Distribution

  • M697X02201300 ()
  • M697X02201301 ()


  • Surgical screwdriver, reusable

Aranax Anterior Cervical Plating System - M697T08612001

SCREW DRIVER
Xtant Medical Holdings, Inc.
T086-1200
In Commercial Distribution

  • M697T08612000 ()
  • M697T08612001 ()


  • Spinal fixation plate, non-bioabsorbable

Xspan Laminoplasty Fixation System - M697T085001011

SHAFT, HEX SCREW DRIVER
Xtant Medical Holdings, Inc.
T085-0010-1
In Commercial Distribution

  • M697T085001010 ()
  • M697T085001011 ()


  • Spinal fixation plate, non-bioabsorbable

Irix-A Lumbar Integrated Fusion System - M697T08000801

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

  • M697T08000800 ()
  • M697T08000801 ()


  • Surgical screwdriver, reusable

Zyfix Spinal Facet Screw System - M697T07600631

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

  • M697T07600630 ()
  • M697T07600631 ()


  • Surgical screwdriver, reusable
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