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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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3.5mm 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
16-12-3535
In Commercial Distribution

  • 10889981052430 ()

  • 3.5mm x 35mm
16-12-3535

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm 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
16-12-3530
In Commercial Distribution

  • 10889981052423 ()

  • 3.5mm x 30mm
16-12-3530

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm 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
16-12-3528
In Commercial Distribution

  • 10889981052416 ()

  • 3.5mm x 28mm
16-12-3528

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm 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
16-12-3526
In Commercial Distribution

  • 10889981052409 ()

  • 3.5mm x 26mm
16-12-3526

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm 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
16-12-3524
In Commercial Distribution

  • 10889981052393 ()

  • 3.5mm x 24mm
16-12-3524

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm 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
16-12-3522
In Commercial Distribution

  • 10889981052386 ()

  • 3.5mm x 22mm
16-12-3522

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm 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
16-12-3518
In Commercial Distribution

  • 10889981052362 ()

  • 3.5mm x 18mm
16-12-3518

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 24mm Standard Screw. 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
16-10-3524
Not in Commercial Distribution

  • 10889981052171 ()

  • 3.5mm x 24mm
16-10-3524

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 20mm Standard Screw. 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
16-10-3520
In Commercial Distribution

  • 10889981052157 ()

  • 3.5mm x 20mm
16-10-3520

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 14mm Standard Screw. 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
16-10-3514
In Commercial Distribution

  • 10889981052126 ()

  • 3.5mm x 14mm
16-10-3514

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