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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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Atoll™ - 10889981052928

Offset Hook (right) - 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
16-21-1905
In Commercial Distribution

  • 10889981052928 ()

  • medium
16-21-1905

  • 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™ - 10889981052874

3.5mm x 400mm Rod. 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
16-18-0400
In Commercial Distribution

  • 10889981052874 ()

  • 3.5mm x 400mm
16-18-0400

  • 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™ - 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

Atoll™ - 10889981052799

4.0mm x 26mm 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
16-13-4026
In Commercial Distribution

  • 10889981052799 ()

  • 4.0mm x 26mm
16-13-4026

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

Atoll™ - 10889981052775

4.0mm x 22mm 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
16-13-4022
In Commercial Distribution

  • 10889981052775 ()

  • 4.0mm x 22mm
16-13-4022

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

Atoll™ - 10889981052744

3.5mm 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
16-13-3538
In Commercial Distribution

  • 10889981052744 ()

  • 3.5mm x 38mm
16-13-3538

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

Atoll™ - 10889981052720

3.5mm 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
16-13-3534
In Commercial Distribution

  • 10889981052720 ()

  • 3.5mm x 34mm
16-13-3534

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