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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 Screw, 04.0 x 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
50-4012
In Commercial Distribution

  • 10889981042561 ()

  • 4.0 Dia X 12mm
50-4012

  • Cannulated surgical drill bit, single-use
Sierra Screw, 04.0 x 10mm. 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
50-4010
In Commercial Distribution

  • 10889981042554 ()

  • 4.0 Dia X 10mm
50-4010

  • Cannulated surgical drill bit, single-use
Sierra Screw, 04.0 x 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
50-4008
Not in Commercial Distribution

  • 10889981042547 ()

  • 4.0 Dia X 8mm
50-4008

  • Cannulated surgical drill bit, single-use
Sierra Screw, 03.5 x 40mm. 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
50-3540
Not in Commercial Distribution

  • 10889981042530 ()

  • 3.5 Dia X 40mm
50-3540

  • Cannulated surgical drill bit, single-use
Sierra Screw, 03.5 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
50-3538
Not in Commercial Distribution

  • 10889981042523 ()

  • 3.5 Dia X 38mm
50-3538

  • Cannulated surgical drill bit, single-use
Sierra Screw, 03.5 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
50-3536
Not in Commercial Distribution

  • 10889981042516 ()

  • 3.5 Dia X 36mm
50-3536

  • Cannulated surgical drill bit, single-use
Sierra Screw, 03.5 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
50-3534
Not in Commercial Distribution

  • 10889981042509 ()

  • 3.5 Dia X 34mm
50-3534

  • Cannulated surgical drill bit, single-use
Sierra Screw, 03.5 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
50-3532
In Commercial Distribution

  • 10889981042493 ()

  • 3.5 Dia X 32mm
50-3532

  • Cannulated surgical drill bit, single-use
Sierra Screw, 03.5 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
50-3530
In Commercial Distribution

  • 10889981042486 ()

  • 3.5 Dia X 30mm
50-3530

  • Cannulated surgical drill bit, single-use
Sierra Screw, 03.5 x 28mm. 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
50-3528
In Commercial Distribution

  • 10889981042479 ()

  • 3.5 Dia X 28mm
50-3528

  • Cannulated surgical drill bit, single-use
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