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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 Screw, 03.5 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
50-3508
Not in Commercial Distribution

  • 10889981042370 ()

  • 3.5 Dia X 8mm
50-3508

  • Cannulated surgical drill bit, single-use
Contoured Crossbar, Xlarge, 3.5 Rod. 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
50-2014
In Commercial Distribution

  • 10889981042363 ()

  • 3.5
50-2014

  • Cannulated surgical drill bit, single-use
Contoured Crossbar, Large, 3.5 Rod. 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
50-2013
In Commercial Distribution

  • 10889981042356 ()

  • 3.5
50-2013

  • Cannulated surgical drill bit, single-use
Contoured Crossbar, Medium, 3.5 Rod. 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
50-2012
In Commercial Distribution

  • 10889981042349 ()

  • 3.5
50-2012

  • Cannulated surgical drill bit, single-use
Contoured Crossbar, Small, 3.5 Rod. 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
50-2011
In Commercial Distribution

  • 10889981042332 ()

  • 3.5
50-2011

  • Cannulated surgical drill bit, single-use
Sierra Locking Cap. 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
50-1000
In Commercial Distribution

  • 10889981042325 ()
50-1000

  • Cannulated surgical drill bit, single-use
Closed Lateral Connector, 3.5 Rod. 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
50-0035
In Commercial Distribution

  • 10889981042318 ()

  • 3.5
50-0035

  • Cannulated surgical drill bit, single-use
Trial Rod, 4.8x600mm
SEASPINE ORTHOPEDICS CORPORATION
91-2984
In Commercial Distribution

  • 10889981082062 ()

  • 4.8x600mm
91-2984

  • Spinal implant trial
Trial Rod, 4.8 x 250mm
SEASPINE ORTHOPEDICS CORPORATION
91-2983
In Commercial Distribution

  • 10889981082055 ()

  • 4.8 x 250mm
91-2983

  • Spinal implant trial
Trial Rod, 4.8 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
91-2982
In Commercial Distribution

  • 10889981082048 ()

  • 4.8 x 110mm
91-2982

  • Spinal implant trial
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