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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™ - 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

Atoll™ - 10889981053079

4.5mm x 50mm Poly Screw Assm. 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
16-12-4550
In Commercial Distribution

  • 10889981053079 ()

  • 4.5mm x 50mm
16-12-4550

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

Atoll™ - 10889981053062

4.5mm x 45mm Poly Screw Assm. 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
16-12-4545
In Commercial Distribution

  • 10889981053062 ()

  • 4.5mm x 45mm
16-12-4545

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

Atoll™ - 10889981053055

4.5mm x 40mm Poly Screw Assm. 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
16-12-4540
In Commercial Distribution

  • 10889981053055 ()

  • 4.5mm x 40mm
16-12-4540

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

Atoll™ - 10889981053048

4.5mm x 35mm Poly Screw Assm. 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
16-12-4535
In Commercial Distribution

  • 10889981053048 ()

  • 4.5mm x 35mm
16-12-4535

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

Atoll™ - 10889981053031

4.5mm x 30mm Poly Screw Assm. 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
16-12-4530
In Commercial Distribution

  • 10889981053031 ()

  • 4.5mm x 30mm
16-12-4530

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

Atoll™ - 10889981053024

4.5mm x 28mm Poly Screw Assm. 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
16-12-4528
In Commercial Distribution

  • 10889981053024 ()

  • 4.5mm x 28mm
16-12-4528

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

Atoll™ - 10889981053017

4.5mm x 26mm Poly Screw Assm. 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
16-12-4526
In Commercial Distribution

  • 10889981053017 ()

  • 4.5mm x 26mm
16-12-4526

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

Atoll™ - 10889981053000

4.5mm x 24mm Poly Screw Assm. 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
16-12-4524
In Commercial Distribution

  • 10889981053000 ()

  • 4.5mm x 24mm
16-12-4524

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

Atoll™ - 10889981052997

4.5mm x 22mm Poly Screw Assm. 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
16-12-4522
In Commercial Distribution

  • 10889981052997 ()

  • 4.5mm x 22mm
16-12-4522

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