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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™ - 10889981042721

Sierra Screw,4.5 Dia 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
50-4510
In Commercial Distribution

  • 10889981042721 ()

  • 4.5 Dia X 10mm
50-4510

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042714

Sierra Screw,4.5 Dia 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
50-4508
Not in Commercial Distribution

  • 10889981042714 ()

  • 4.5 Dia X 8mm
50-4508

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042707

Sierra Screw, 04.0 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
50-4040
Not in Commercial Distribution

  • 10889981042707 ()

  • 4.0 Dia X 40mm
50-4040

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042684

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™ - 10889981042660

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™ - 10889981042646

Sierra Screw, 04.0 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
50-4028
In Commercial Distribution

  • 10889981042646 ()

  • 4.0 Dia X 28mm
50-4028

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042608

Sierra Screw, 04.0 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
50-4020
In Commercial Distribution

  • 10889981042608 ()

  • 4.0 Dia X 20mm
50-4020

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042585

Sierra Screw, 04.0 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
50-4016
In Commercial Distribution

  • 10889981042585 ()

  • 4.0 Dia X 16mm
50-4016

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042561

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™ - 10889981042554

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
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