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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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Patient-Fitted TMJ Reconstructive Prosthesis System - 07613327626537

Driver Blade
TMJ Solutions, Inc.
60-0110
In Commercial Distribution



  • Orthopaedic prosthesis implantation positioning instrument, reusable

Patient-Fitted TMJ Reconstructive Prosthesis System - 07613327626520

TMJ Driver Handle and Blade (Loaner)
TMJ Solutions, Inc.
60-0010
In Commercial Distribution



  • Joint prosthesis implantation kit, reusable

Shoulder Innovations Inset Reverse Total Shoulder - B1132R2GT400200

Shoulder Innovations Inset Reverse Total Shoulder - RSA T20 Driver
Shoulder Innovations, Inc.
RSA T20 Driver
In Commercial Distribution

  • B1132R2GT400200 ()
2R2GT40020

  • Total shoulder prosthesis
  • Total reverse shoulder prosthesis
  • Orthopaedic prosthesis implantation positioning instrument, reusable

Aligned Medical Solutions - B098DDS11560

Snag Resistant Webster Needle Driver
Aligned Medical Solutions
DDS1156
In Commercial Distribution

  • B098DDS11561 ()
  • B098DDS11560 ()
DDS1156

  • General surgical procedure kit, non-medicated, single-use

Shoulder Innovations TSA System - B1130S1GS000040

No Description
Shoulder Innovations, Inc.
Glenoid Driver Grip
In Commercial Distribution

  • B1130S1GS000040 ()
0S1GS00004

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Shoulder Innovations, LLC - B1130S1GS000020

No Description
Shoulder Innovations, Inc.
Glenoid Driver
In Commercial Distribution

  • B1130S1GS000020 ()
0S1GS00002

  • Orthopaedic prosthesis implantation positioning instrument, reusable

Mallet - B114214000

Mallet used for cervical inter-vertebral body spacer placement
CALVARY SPINE, LLC
Mallet
In Commercial Distribution

  • B114214000 ()
214-00

  • Surgical mallet

Shoulder Innovations Inset Reverse Total Shoulder - B1132R2HE000020

Shoulder Innovations Inset Reverse Total Shoulder - RSA Screw Driver Handle Extractor
Shoulder Innovations, Inc.
RSA Handle Extractor
In Commercial Distribution

  • B1132R2HE000020 ()
2R2HE00002

  • Total shoulder prosthesis
  • Total reverse shoulder prosthesis
  • Orthopaedic prosthesis implantation positioning instrument, reusable

Shoulder Innovations Inset Reverse Total Shoulder - B1132R2GT400150

Shoulder Innovations Inset Reverse Total Shoulder - RSA T15 Driver
Shoulder Innovations, Inc.
RSA T15 Driver
In Commercial Distribution

  • B1132R2GT400150 ()
2R2GT40015

  • Total shoulder prosthesis
  • Total reverse shoulder prosthesis
  • Orthopaedic prosthesis implantation positioning instrument, reusable

Shoulder Innovations Inset Reverse Total Shoulder - B1132R2GT200000

Shoulder Innovations Inset Reverse Total Shoulder - RSA Screw Driver Handle
Shoulder Innovations, Inc.
RSA Screw Driver Handle
In Commercial Distribution

  • B1132R2GT200000 ()
2R2GT20000

  • Total shoulder prosthesis
  • Total reverse shoulder prosthesis
  • Orthopaedic prosthesis implantation positioning instrument, reusable
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