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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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Butrex Buttress Plating System - M697X02300551

Screw Removal Device, ButreX System
Xtant Medical Holdings, Inc.
X023-0055
Not in Commercial Distribution

  • M697X02300550 ()
  • M697X02300551 ()


  • Spinal fixation plate, non-bioabsorbable

Butrex Buttress Plating System - M697X02300501

Screwdriver Assembly
Xtant Medical Holdings, Inc.
X023-0050
Not in Commercial Distribution

  • M697X02300500 ()
  • M697X02300501 ()


  • Spinal fixation plate, non-bioabsorbable

Butrex Buttress Plating System - M697X02300451

Assembly, 4.3mm Tap
Xtant Medical Holdings, Inc.
X023-0045
Not in Commercial Distribution

  • M697X02300450 ()
  • M697X02300451 ()

  • Outer Diameter: 4.3 Millimeter


  • Spinal fixation plate, non-bioabsorbable

Butrex Buttress Plating System - M697X02300401

Assembly, Double Barrel Guide
Xtant Medical Holdings, Inc.
X023-0040
Not in Commercial Distribution

  • M697X02300400 ()
  • M697X02300401 ()


  • Spinal fixation plate, non-bioabsorbable

Butrex Buttress Plating System - M697X02300331

24mm Drill Bit, ButreX System
Xtant Medical Holdings, Inc.
X023-0033
Not in Commercial Distribution

  • M697X02300330 ()
  • M697X02300331 ()

  • Length: 24 Millimeter


  • Spinal fixation plate, non-bioabsorbable

Butrex Buttress Plating System - M697X02300321

22mm Drill Bit, ButreX System
Xtant Medical Holdings, Inc.
X023-0032
Not in Commercial Distribution

  • M697X02300320 ()
  • M697X02300321 ()

  • Length: 22 Millimeter


  • Spinal fixation plate, non-bioabsorbable

Butrex Buttress Plating System - M697X02300311

20mm Drill Bit, Butrex System
Xtant Medical Holdings, Inc.
X023-0031
Not in Commercial Distribution

  • M697X02300310 ()
  • M697X02300311 ()

  • Length: 20 Millimeter


  • Spinal fixation plate, non-bioabsorbable

Butrex Buttress Plating System - M697X02300001

Butrex System Set
Xtant Medical Holdings, Inc.
X023-0000
Not in Commercial Distribution

  • M697X02300000 ()
  • M697X02300001 ()


  • Spinal fixation plate, non-bioabsorbable

PROFEMUR® - M684PRPR00121

PROFEMUR® PRESERVE STEM SIZE 12
Microport Orthopedics Inc.
PRPR0012
In Commercial Distribution

  • PRPR0012 ()
  • M684PRPR00121 ()
PRPR0012

  • Coated femoral stem prosthesis, modular

PROFEMUR® - M684PRPR00111

PROFEMUR® PRESERVE STEM SIZE 11
Microport Orthopedics Inc.
PRPR0011
In Commercial Distribution

  • PRPR0011 ()
  • M684PRPR00111 ()
PRPR0011

  • Coated femoral stem prosthesis, modular
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