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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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OIC Pedicle Screw System - M696SP200030

SET SCREW DRIVER
ORTHOPAEDIC IMPLANT COMPANY, THE
SP20003
Not in Commercial Distribution

  • M696SP200030 ()


  • Surgical screwdriver, reusable

OIC Pedicle Screw System - M696SP200010

SET SCREW INSTALLATION DRIVER
ORTHOPAEDIC IMPLANT COMPANY, THE
SP20001
Not in Commercial Distribution

  • M696SP200010 ()


  • 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 - M697X02201391

Fortex Adjustment Screwdriver
Xtant Medical Holdings, Inc.
X022-0139
In Commercial Distribution

  • M697X02201390 ()
  • M697X02201391 ()


  • 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

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

Irix-A Lumbar Integrated Fusion System - M697T08000761

Irix A Universal Joint Screwdriver
Xtant Medical Holdings, Inc.
T080-0076
In Commercial Distribution

  • M697T08000760 ()
  • M697T08000761 ()


  • Surgical screwdriver, reusable

Irix-A Lumbar Integrated Fusion System - M697T08000701

Irix A Straight Screwdriver
Xtant Medical Holdings, Inc.
T080-0070
In Commercial Distribution

  • M697T08000700 ()
  • M697T08000701 ()


  • Surgical screwdriver, reusable

Irix-A Lumbar Integrated Fusion System - M697T08000331

Irix A Mallet/Extractor
Xtant Medical Holdings, Inc.
T080-0033
In Commercial Distribution

  • M697T08000330 ()
  • M697T08000331 ()


  • Surgical mallet
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