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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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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™ - 10889981052973

4.5mm x 18mm 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
16-12-4518
In Commercial Distribution

  • 10889981052973 ()

  • 4.5mm x 18mm
16-12-4518

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

Atoll™ - 10889981052942

4.5mm x 12mm 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
16-12-4512
In Commercial Distribution

  • 10889981052942 ()

  • 4.5mm x 12mm
16-12-4512

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

Atoll™ - 10889981052911

Offset Hook (right) - small. 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
16-21-1904
In Commercial Distribution

  • 10889981052911 ()

  • small
16-21-1904

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

Atoll™ - 10889981052898

Offset Hook (left) - small. 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
16-21-1804
In Commercial Distribution

  • 10889981052898 ()

  • small
16-21-1804

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

Atoll™ - 10889981052867

Locking Screw Assembly. 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
16-17-0000
In Commercial Distribution

  • 10889981052867 ()

  • N/A
16-17-0000

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

Atoll™ - 10889981052850

4.0mm x 38mm Smooth Shaft 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
16-13-4038
In Commercial Distribution

  • 10889981052850 ()

  • 4.0mm x 38mm
16-13-4038

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

Atoll™ - 10889981052843

4.0mm x 36mm Smooth Shaft 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
16-13-4036
In Commercial Distribution

  • 10889981052843 ()

  • 4.0mm x 36mm
16-13-4036

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

Atoll™ - 10889981052836

4.0mm x 34mm Smooth Shaft 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
16-13-4034
In Commercial Distribution

  • 10889981052836 ()

  • 4.0mm x 34mm
16-13-4034

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

Atoll™ - 10889981052829

4.0mm x 32mm Smooth Shaft 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
16-13-4032
In Commercial Distribution

  • 10889981052829 ()

  • 4.0mm x 32mm
16-13-4032

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