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

  • B1132R2GT100000 ()
2R2GT10000

  • Total shoulder prosthesis
  • Total reverse shoulder prosthesis
  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
CAYENNE MEDICAL, INC.
CM1345
In Commercial Distribution

CM1345

  • Orthopaedic inorganic implant inserter/extractor, reusable
No Description
XENCO MEDICAL LLC
XM-217-0000
In Commercial Distribution

  • B064XM21700001 ()


  • Bone file/rasp, manual, reusable
No Description
XENCO MEDICAL LLC
XM-216-0015
In Commercial Distribution

  • B064XM21600151 ()


  • Spinal fixation plate, non-bioabsorbable
The Integra External Fixation System set consists of rings and footplates. These devices are used for stability and structure. The external fixation device is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
Ascension Orthopedics, Inc.
XFIX5RINGIMP
Not in Commercial Distribution

  • M268XFIX5RINGIMP1 ()
  • 10381780125730 ()
XFIX5RINGIMP

  • External orthopaedic fixation system, reusable
The Integra External Fixation System set consists of rings, footplates, anterior cross bars, and a rockerbottom. These devices are used for stability and structure. The external fixation device is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
Ascension Orthopedics, Inc.
XFIX4RCKRIMP
Not in Commercial Distribution

  • M268XFIX4RCKRIMP1 ()
  • 10381780125723 ()
XFIX4RCKRIMP

  • External orthopaedic fixation system, reusable
The Integra External Fixation System set consists of struts, rods, and hex posts. These devices are used for support in the construct. Plates and a universal joint are also included. The external fixation device is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
Ascension Orthopedics, Inc.
XFIX2RODSIMP
Not in Commercial Distribution

  • M268XFIX2RODSIMP1 ()
  • 10381780125716 ()
XFIX2RODSIMP

  • External orthopaedic fixation system, reusable
The Integra External Fixation System set consists of wires, half-pins, nuts, and bolts. Instruments are also included to aid in assembly. The external fixation device is intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality.
Ascension Orthopedics, Inc.
XFIX1BOLTIMP
Not in Commercial Distribution

  • M268XFIX1BOLTIMP1 ()
  • 10381780125709 ()
XFIX1BOLTIMP

  • External orthopaedic fixation system, reusable
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