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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Mariner RDX Derotation Sleeve
SEASPINE ORTHOPEDICS CORPORATION
SR-1102
In Commercial Distribution

  • 10889981319588 ()
SR-1102

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Mariner RDX Derotation Tube
SEASPINE ORTHOPEDICS CORPORATION
SR-1101
In Commercial Distribution

  • 10889981319571 ()
SR-1101

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Mariner Deformity Iliac Set, Navigated
SEASPINE ORTHOPEDICS CORPORATION
MD3-207200
In Commercial Distribution

  • 10889981309206 ()
MD3-207200

  • Instrument tray, reusable
Angled TruProfile Plate Inserter
SEASPINE ORTHOPEDICS CORPORATION
SR-0975
In Commercial Distribution

  • 10889981308803 ()
SR-0975

  • Orthopaedic implant inserter/extractor, reusable
Top-Loading Connector Caddy
SEASPINE ORTHOPEDICS CORPORATION
99-9017
In Commercial Distribution

  • 10889981308650 ()
99-9017

  • Instrument tray, reusable
Sierra Screw, 04.0 x 38mm. 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
50-4038
Not in Commercial Distribution

  • 10889981042691 ()

  • 4.0 Dia X 38mm
50-4038

  • Cannulated surgical drill bit, single-use
Sierra Screw, 04.0 x 36mm. 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
50-4036
Not in Commercial Distribution

  • 10889981042684 ()

  • 4.0 Dia X 36mm
50-4036

  • Cannulated surgical drill bit, single-use
Sierra Screw, 04.0 x 34mm. 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
50-4034
Not in Commercial Distribution

  • 10889981042677 ()

  • 4.0 Dia X 34mm
50-4034

  • Cannulated surgical drill bit, single-use
Sierra Screw, 04.0 x 32mm. 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
50-4032
Not in Commercial Distribution

  • 10889981042660 ()

  • 4.0 Dia X 32mm
50-4032

  • Cannulated surgical drill bit, single-use
Sierra Screw, 04.0 x 30mm. 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
50-4030
Not in Commercial Distribution

  • 10889981042653 ()

  • 4.0 Dia X 30mm
50-4030

  • Cannulated surgical drill bit, single-use
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