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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™ - 10889981042349

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

Sierra™ - 10889981042332

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™ - 10889981042325

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

Sierra™ - 10889981042318

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

UCR - 10889981036201

PEDICLE 9.0 X 5.0 MM
SEASPINE ORTHOPEDICS CORPORATION
14-9050
In Commercial Distribution

  • 10889981036201 ()

  • 9.0 X 5.0 MM
14-9050

  • Bone-screw internal spinal fixation system, non-sterile

UCR - 10889981036195

LAMINAR 7.0 X 8.0 MM
SEASPINE ORTHOPEDICS CORPORATION
14-7080
In Commercial Distribution

  • 10889981036195 ()

  • 7.0 X 8.0 MM
14-7080

  • Bone-screw internal spinal fixation system, non-sterile

UCR - 10889981036188

LAMINAR 7.0 X 6.5 MM
SEASPINE ORTHOPEDICS CORPORATION
14-7065
In Commercial Distribution

  • 10889981036188 ()

  • 7.0 X 6.5 MM
14-7065

  • Bone-screw internal spinal fixation system, non-sterile

Atoll - 10889981034511

Pre-Bent Occipital Rod (110 degrees -240mm). The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-33-0240
In Commercial Distribution

  • 10889981034511 ()

  • 110 degrees - 240mm
16-33-0240

  • Bone-screw internal spinal fixation system, non-sterile

Atoll - 10889981034504

Pre-Bent Occipital Rod (110 degrees -205mm). The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-33-0205
In Commercial Distribution

  • 10889981034504 ()

  • 110 degrees - 205mm
16-33-0205

  • Bone-screw internal spinal fixation system, non-sterile

Atoll - 10889981034498

Pre-Bent Occipital Rod (110 degrees -170mm). The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-33-0170
In Commercial Distribution

  • 10889981034498 ()

  • 110 degrees - 170mm
16-33-0170

  • Bone-screw internal spinal fixation system, non-sterile
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