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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 Device Size Type Device Class Implantable

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4.0mm Occipital Screw, 12mm. 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
16-31-4012
Not in Commercial Distribution

  • 10889981034030 ()

  • 4.0mm, 12mm
16-31-4012

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm Occipital Screw, 11mm. 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
16-31-4011
Not in Commercial Distribution

  • 10889981034023 ()

  • 4.0mm, 11mm
16-31-4011

  • Bone-screw internal spinal fixation system, non-sterile
Offset Hook (left) - medium. 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
16-21-1805
In Commercial Distribution

  • 10889981033842 ()

  • medium
16-21-1805

  • Bone-screw internal spinal fixation system, non-sterile
Closed Lateral Offset Asm. 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
16-24-0011
Not in Commercial Distribution

  • 10889981033774 ()
16-24-0011

  • Bone-screw internal spinal fixation system, non-sterile
Inline 3.5mm to 5.5mm Connector Asm. 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
16-23-5520
In Commercial Distribution

  • 10889981033736 ()

  • 3.5mm to 5.5mm
16-23-5520

  • Bone-screw internal spinal fixation system, non-sterile
OFFSET HOOK 5.5 X 9.5mm RIGHT. The Malibu system contains polyaxial screws of varying reduction height, cannulated polyaxial screws of varying reduction height, uniplanar screws of varying reduction height, monoaxial screws, iliac onoaxial screws, rods, rod connectors, screw spacers, crossbars, sublaminar wires and hooks. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobalt.
Seaspine Orthopedics Corporation
17-3595
In Commercial Distribution

  • 10889981028190 ()

  • 5.5mm X 9.5mm
17-3595

  • Bone-screw internal spinal fixation system, non-sterile
OFFSET HOOK 5.5 X 9.5mm LEFT. The Malibu system contains polyaxial screws of varying reduction height, cannulated polyaxial screws of varying reduction height, uniplanar screws of varying reduction height, monoaxial screws, iliac onoaxial screws, rods, rod connectors, screw spacers, crossbars, sublaminar wires and hooks. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobalt.
Seaspine Orthopedics Corporation
17-2595
In Commercial Distribution

  • 10889981028183 ()

  • 5.5mm X 9.5mm
17-2595

  • Bone-screw internal spinal fixation system, non-sterile
ANGLED HOOK, 5.5 X 6.5mm, RIGHT. The Malibu system contains polyaxial screws of varying reduction height, cannulated polyaxial screws of varying reduction height, uniplanar screws of varying reduction height, monoaxial screws, iliac onoaxial screws, rods, rod connectors, screw spacers, crossbars, sublaminar wires and hooks. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobalt.
Seaspine Orthopedics Corporation
17-1565
In Commercial Distribution

  • 10889981028176 ()

  • 5.5 X 6.5mm, RIGHT
17-1565

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