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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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Calix Spinal Implant System - M697X03422311

Sterilization Case, Calix, TLIF Trials
Xtant Medical Holdings, Inc.
X034-2231
In Commercial Distribution

  • M697X03422310 ()
  • M697X03422311 ()


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03422211

Sterilization Case, Calix, PLIF Trials
Xtant Medical Holdings, Inc.
X034-2221
In Commercial Distribution

  • M697X03422210 ()
  • M697X03422211 ()


  • Polymeric spinal interbody fusion cage

Calix Spinal Implant System - M697X03422031

Sterilization Case, Calix, Disc Preparation
Xtant Medical Holdings, Inc.
X034-2203
In Commercial Distribution

  • M697X03422030 ()
  • M697X03422031 ()


  • Polymeric spinal interbody fusion cage

Fortex Pedicle Screw System - M697X02201961

Sterilization Case II, Fortex, Implant
Xtant Medical Holdings, Inc.
X022-0196
In Commercial Distribution

  • M697X02201960 ()
  • M697X02201961 ()


  • Device sterilization/disinfection container, reusable

Fortex Pedicle Screw System - M697X02201971

Sterilization Case II, Fortex, Instrument
Xtant Medical Holdings, Inc.
X022-0197
In Commercial Distribution

  • M697X02201970 ()
  • M697X02201971 ()


  • Device sterilization/disinfection container, reusable

Xpress Minimally Invasive Pedicle Screw System - M697X07300051

Sterilization Case II, Xpress, Instrument
Xtant Medical Holdings, Inc.
X073-0005
In Commercial Distribution

  • M697X07300050 ()
  • M697X07300051 ()


  • Device sterilization/disinfection container, reusable

Xpress Minimally Invasive Pedicle Screw System - M697X07300041

Sterilization Case I, Xpress, Instrument
Xtant Medical Holdings, Inc.
X073-0004
In Commercial Distribution

  • M697X07300040 ()
  • M697X07300041 ()


  • Device sterilization/disinfection container, reusable

Irix-C Cervical Integrated Fusion System - M697X06600061

STERILIZATION CASE, ADDITIONAL INSTRUMENTS, IRIX-C
Xtant Medical Holdings, Inc.
X066-0006
In Commercial Distribution

  • M697X06600060 ()
  • M697X06600061 ()


  • Polymeric spinal interbody fusion cage

CONNEXX - 04063006001194

ACC. SLIM-RIC BT CHARGING CASE
Ws Audiology Usa, Inc.
SLIM-RIC BT CHARGING CASE
In Commercial Distribution

  • 04063006001194 ()
10962493

  • Noninvasive device battery charger

CastleLoc Pectus Bar System Instrument Set - 08809986460424

Basic Instrument Case - Screw Caddy
L&K BIOMED CO. ,LTD.
PB05-1005
In Commercial Distribution

  • 08809986460424 ()
PB05-1005

  • Orthopaedic prosthesis implantation positioning instrument, reusable
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