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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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Inion SPINE instrumentation - 06438408005022

Screw removal instrument
Inion Oy
1
In Commercial Distribution

  • M224INS95539 ()
  • 06438408005022 ()
INS-9553

  • Surgical screwdriver, reusable

Inion FreedomScrew instruments - 06438408003943

Screwdriver shaft, hex 3.5 mm, cannulated
Inion Oy
1
In Commercial Distribution

  • M224IFS90029 ()
  • 06438408003943 ()
IFS-9002

  • Surgical screwdriver, reusable

Inion FreedomScrew instruments - 06438408003936

Screwdriver shaft, hex 2.5 mm
Inion Oy
1
In Commercial Distribution

  • M224IFS90019 ()
  • 06438408003936 ()
IFS-9001

  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697X06706301

SCREW HEAD TURNER
Xtant Medical Holdings, Inc.
X067-0630
Not in Commercial Distribution

  • M697X06706300 ()
  • M697X06706301 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697X06705201

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

  • M697X06705200 ()
  • M697X06705201 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697X06704401

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

  • M697X06704400 ()
  • M697X06704401 ()


  • Surgical screwdriver, reusable

Certex Spinal Fixation System - M697X06704251

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

  • M697X06704250 ()
  • M697X06704251 ()


  • Surgical screwdriver, reusable

Fortex Pedicle Screw System - M697X06401401

Reduction Pedicle Screwdriver Assembly
Xtant Medical Holdings, Inc.
X064-0140
In Commercial Distribution

  • M697X06401400 ()
  • M697X06401401 ()


  • Surgical screwdriver, reusable

Fortex Pedicle Screw System - M697X02203401

Extended T-Handle Cap Introducer Assembly
Xtant Medical Holdings, Inc.
X022-0340
In Commercial Distribution

  • M697X02203400 ()
  • M697X02203401 ()


  • Surgical screwdriver, reusable

Fortex Pedicle Screw System - M697X02202401

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

  • M697X02202400 ()
  • M697X02202401 ()


  • Surgical screwdriver, reusable
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