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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 Type Device Class Implantable

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Sierra™ - 10889981042929

Occipital Screw, 8mm. 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
50-5008
In Commercial Distribution

  • 10889981042929 ()

  • 8mm
50-5008

  • Cannulated surgical drill bit, single-use

Shoreline ASC - 10889981125097

8mm, Locking Cover
SEASPINE ORTHOPEDICS CORPORATION
85-2108
In Commercial Distribution

  • 10889981125097 ()

  • 8mm
85-2108

  • Vertebral body prosthesis, non-sterile

Shoreline ASC - 10889981124342

8mm, 4-Hole Anterior Plate
SEASPINE ORTHOPEDICS CORPORATION
85-0708
In Commercial Distribution

  • 10889981124342 ()

  • 8mm
85-0708

  • Vertebral body prosthesis, non-sterile

Shoreline ASC - 10889981124267

8mm, 3-Hole Anterior Plate
SEASPINE ORTHOPEDICS CORPORATION
85-0608
In Commercial Distribution

  • 10889981124267 ()

  • 8mm
85-0608

  • Vertebral body prosthesis, non-sterile

Shoreline ASC - 10889981124182

8mm, 2-Hole Anterior Plate
SEASPINE ORTHOPEDICS CORPORATION
85-0508
In Commercial Distribution

  • 10889981124182 ()

  • 8mm
85-0508

  • Vertebral body prosthesis, non-sterile

Vu ePOD™ - 10889981036720

8mm Inserter
SEASPINE ORTHOPEDICS CORPORATION
14-40-0008
In Commercial Distribution

  • 10889981036720 ()

  • 8mm
14-40-0008

  • Orthopaedic implant inserter/extractor, reusable

Spinous Process System - 10889981096243

8mm Trial, Spinous Process Spacer
SEASPINE ORTHOPEDICS CORPORATION
95-3108
In Commercial Distribution

  • 10889981096243 ()

  • 8mm
95-3108

  • Spinal implant trial

Sierra - 10889981095215

Occipital Tap, 8mm
SEASPINE ORTHOPEDICS CORPORATION
95-0217
In Commercial Distribution

  • 10889981095215 ()

  • 8mm
95-0217

  • Bone tap, reusable

Sierra - 10889981095062

Occipital Drill, 8mm
SEASPINE ORTHOPEDICS CORPORATION
95-0202
In Commercial Distribution

  • 10889981095062 ()

  • 8mm
95-0202

  • Surgical screwdriver, reusable

Sierra - 10889981094782

Flexible Occipital Drill, 8mm
SEASPINE ORTHOPEDICS CORPORATION
95-0172
In Commercial Distribution

  • 10889981094782 ()

  • 8mm
95-0172

  • Surgical screwdriver, reusable
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