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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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Ext. Tab Fenestrated Polyaxial Screw, 7.50mm x 50mm
SEASPINE ORTHOPEDICS CORPORATION
18-26-7550
In Commercial Distribution

  • 10889981020507 ()

  • 7.50mm x 50mm
18-26-7550

  • Bone-screw internal spinal fixation system, non-sterile
Ext. Tab Fenestrated Polyaxial Screw, 7.50mm x 45mm
SEASPINE ORTHOPEDICS CORPORATION
18-26-7545
In Commercial Distribution

  • 10889981020491 ()

  • 7.50mm x 45mm
18-26-7545

  • Bone-screw internal spinal fixation system, non-sterile
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
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 Screw, 04.0 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
50-4026
In Commercial Distribution

  • 10889981042639 ()

  • 4.0 Dia X 26mm
50-4026

  • Cannulated surgical drill bit, single-use
Sierra Screw, 04.0 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
50-4024
In Commercial Distribution

  • 10889981042622 ()

  • 4.0 Dia X 24mm
50-4024

  • Cannulated surgical drill bit, single-use
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