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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Lateral Paddle Distractor, 12mm
SEASPINE ORTHOPEDICS CORPORATION
95-6272
In Commercial Distribution

  • 10889981098322 ()

  • 12mm
95-6272

  • Orthopaedic surgical distractor, internal
Curved Paddle Shaver, 12mm
SEASPINE ORTHOPEDICS CORPORATION
95-6242
In Commercial Distribution

  • 10889981098155 ()

  • 12mm
95-6242

  • Bone file
Parallel Paddle Shaver, 12mm
SEASPINE ORTHOPEDICS CORPORATION
95-6222
In Commercial Distribution

  • 10889981098070 ()

  • 12mm
95-6222

  • Bone file
Wedge Distractor, 12mm
SEASPINE ORTHOPEDICS CORPORATION
95-5826
In Commercial Distribution

  • 10889981097554 ()

  • 12mm
95-5826

  • Orthopaedic surgical distractor, internal
Modular Bullet Paddle Distractor 12mm
SEASPINE ORTHOPEDICS CORPORATION
95-5812
In Commercial Distribution

  • 10889981097431 ()

  • 12mm
95-5812

  • Orthopaedic surgical distractor, internal
Mask, 12mm
SEASPINE ORTHOPEDICS CORPORATION
95-5712
In Commercial Distribution

  • 10889981097318 ()

  • 12mm
95-5712

  • Spinal implant trial
Paddle Distractor, 12mm
SEASPINE ORTHOPEDICS CORPORATION
95-5612
In Commercial Distribution

  • 10889981097202 ()

  • 12mm
95-5612

  • Orthopaedic surgical distractor, internal
12mm Wide Removal Tool. 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
98-2012
Not in Commercial Distribution

  • 10889981049447 ()

  • 12mm
98-2012

  • Orthopaedic implant inserter/extractor, reusable
Occipital Screw, 12mm. 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
50-5012
In Commercial Distribution

  • 10889981042967 ()

  • 12mm
50-5012

  • Cannulated surgical drill bit, single-use
12mm, Locking Cover, Backup
SEASPINE ORTHOPEDICS CORPORATION
85-2312
In Commercial Distribution

  • 10889981140342 ()

  • 12mm
85-2312

  • Vertebral body prosthesis, non-sterile
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