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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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Decima Spine Instrument Kit - 00857360007060

INSERTION TOOL
DECIMA SPINE, INC.
6095
In Commercial Distribution

  • 00857360007060 ()
6095

  • Orthopaedic inorganic implant inserter/extractor, reusable

Decima Spine Instrument Kit - 00857360007053

Driver
DECIMA SPINE, INC.
6094
In Commercial Distribution

  • 00857360007053 ()
6094

  • Surgical screwdriver, reusable

Decima Spine Instrument Kit - 00857360007046

Countersink
DECIMA SPINE, INC.
6093
In Commercial Distribution

  • 00857360007046 ()
6093

  • Surgical countersink, reusable

Decima Spine Instrument Kit - 00857360007015

Quick Release Handle
DECIMA SPINE, INC.
6079
In Commercial Distribution

  • 00857360007015 ()
6079

  • Surgical instrument handle, non-torque-limiting

Shaver System - 00857326005659

Handpiece
STRYKER CORPORATION
SSA-104
In Commercial Distribution

  • 00857326005659 ()


  • ENT shaver system handpiece

Entellus Medical - 00857326005635

Shaver System
STRYKER CORPORATION
SS-100
In Commercial Distribution

  • 00857326005635 ()


  • ENT shaver system

AUDERE C CERVICAL IMPLANT 10 MM X 6° - 00857215007931

THE AUDERE C SPINAL INTERVETEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVETEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE INVERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
MET 1 TECHNOLOGIES, LLC
40100006
In Commercial Distribution

  • 00857215007931 ()

  • Angle: 6 degree
  • Height: 10 Millimeter
40100006

  • Ceramic spinal interbody fusion cage

AUDERE C CERVICAL IMPLANT 9MM X 6° - 00857215007924

THE AUDERE C SPINAL INTERVETEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVETEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE INVERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
MET 1 TECHNOLOGIES, LLC
40090006
In Commercial Distribution

  • 00857215007924 ()

  • Angle: 6 degree
  • Height: 9 Millimeter
40090006

  • Ceramic spinal interbody fusion cage

AUDERE C CERVICAL IMPLANT 8MM X 6° - 00857215007917

THE AUDERE C SPINAL INTERVETEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVETEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE INVERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
MET 1 TECHNOLOGIES, LLC
40080006
In Commercial Distribution

  • 00857215007917 ()

  • Angle: 6 degree
  • Height: 8 Millimeter
40080006

  • Ceramic spinal interbody fusion cage

AUDERE C CERVICAL IMPLANT 7MM X 6° - 00857215007900

THE AUDERE C SPINAL INTERVETEBRAL BODY FUSION DEVICE IS A CERVICAL INTERVETEBRAL BODY FUSION DEVICE THAT IS IMPLANTED INTO THE INVERTEBRAL BODY SPACE TO IMPROVE STABILITY OF THE SPINE WHILE SUPPORTING FUSION. A VARIETY OF IMPLANT SIZES ARE PROVIDED TO ACCOMMODATE INDIVIDUAL PATIENT ANATOMY.
MET 1 TECHNOLOGIES, LLC
40070006
In Commercial Distribution

  • 00857215007900 ()

  • Angle: 6 degree
  • Height: 7 Millimeter
40070006

  • Ceramic spinal interbody fusion cage
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