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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™ - 10889981042486

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™ - 10889981042479

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

Sierra™ - 10889981042462

Sierra Screw, 03.5 x 26mm. 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
50-3526
In Commercial Distribution

  • 10889981042462 ()

  • 3.5 Dia X 26mm
50-3526

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042455

Sierra Screw, 03.5 x 24mm. 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
50-3524
In Commercial Distribution

  • 10889981042455 ()

  • 3.5 Dia X 24mm
50-3524

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042448

Sierra Screw, 03.5 x 22mm. 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
50-3522
In Commercial Distribution

  • 10889981042448 ()

  • 3.5 Dia X 22mm
50-3522

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042431

Sierra Screw, 03.5 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
50-3520
In Commercial Distribution

  • 10889981042431 ()

  • 3.5 Dia X 20mm
50-3520

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042424

Sierra Screw, 03.5 x 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
50-3518
In Commercial Distribution

  • 10889981042424 ()

  • 3.5 Dia X 18mm
50-3518

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042417

Sierra Screw, 03.5 x 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
50-3516
In Commercial Distribution

  • 10889981042417 ()

  • 3.5 Dia X 16mm
50-3516

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042400

Sierra Screw, 03.5 x 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
50-3514
In Commercial Distribution

  • 10889981042400 ()

  • 3.5 Dia X 14mm
50-3514

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042394

Sierra Screw, 03.5 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
50-3512
In Commercial Distribution

  • 10889981042394 ()

  • 3.5 Dia X 12mm
50-3512

  • Cannulated surgical drill bit, single-use
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