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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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Sierra™ - 10889981043056

Rod, 3.5 x 20mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-6020
Not in Commercial Distribution

  • 10889981043056 ()

  • 3.5 X 20mm
50-6020

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043025

Occipital Screw, 18mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-5018
Not in Commercial Distribution

  • 10889981043025 ()

  • 18mm
50-5018

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043018

Occipital Screw, 17mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-5017
Not in Commercial Distribution

  • 10889981043018 ()

  • 17mm
50-5017

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981043001

Occipital Screw, 16mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-5016
Not in Commercial Distribution

  • 10889981043001 ()

  • 16mm
50-5016

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042981

Occipital Screw, 14mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
Seaspine Orthopedics Corporation
50-5014
In Commercial Distribution

  • 10889981042981 ()

  • 14mm
50-5014

  • Cannulated surgical drill bit, single-use

ERGONOMIC HEAD DRIVER - 00880304309388

No Description
Biomet Orthopedics, LLC
31-399999
In Commercial Distribution

  • 00880304309388 ()
31-399999

  • Orthopaedic implant driver

SCREW INSERTER - 00880304288805

No Description
Biomet Orthopedics, LLC
245015
In Commercial Distribution

  • 00880304288805 ()
245015

  • Surgical screwdriver, reusable

Integra Expandable Interbody - 10889981049423

Expansion Driver. The Integra Expandable IBD System consists of lumbar interbody fusion devices manufactured from PEEK-OPTIMA® LT1 (ASYM F2026), titanium (Ti-6AI-4V ELI per ASTM F136) and cobalt chromium (Co-28Cr-6Mo per ASTM F1537) materials, with radiopaque tantalum markers (ASTM F560). These implants are generally box shaped with surface teeth and a central channel to be filled with autogenous bone graft.
Seaspine Orthopedics Corporation
98-2010
Not in Commercial Distribution

  • 10889981049423 ()

  • 10mm
98-2010

  • Orthopaedic inorganic implant inserter/extractor, reusable

SUNDIAL(R) - 00880304302532

No Description
Biomet Orthopedics, LLC
31-108100
In Commercial Distribution

  • 00880304302532 ()
31-108100

  • Surgical screwdriver, reusable

FREEDOM HEAD DRIVER - 00880304301993

No Description
Biomet Orthopedics, LLC
31-107036
In Commercial Distribution

  • 00880304301993 ()
31-107036

  • Surgical screwdriver, reusable
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