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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 28mm 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
16-10-3528
In Commercial Distribution

  • 10889981052195 ()

  • 3.5mm x 28mm
16-10-3528

  • 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 22mm 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
16-10-3522
In Commercial Distribution

  • 10889981052164 ()

  • 3.5mm x 22mm
16-10-3522

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 16mm 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
16-10-3516
In Commercial Distribution

  • 10889981052133 ()

  • 3.5mm x 16mm
16-10-3516

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 10mm 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
16-10-3510
In Commercial Distribution

  • 10889981052102 ()

  • 3.5mm x10mm
16-10-3510

  • Bone-screw internal spinal fixation system, non-sterile
Pre-Bent Occipital Rod (110 degrees -170mm). 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
16-33-0170
In Commercial Distribution

  • 10889981034498 ()

  • 110 degrees - 170mm
16-33-0170

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Occipital Screw, 17mm. 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
16-31-4517
Not in Commercial Distribution

  • 10889981034214 ()

  • 4.5mm, 17mm
16-31-4517

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Occipital Screw, 7mm. 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
16-31-4507
Not in Commercial Distribution

  • 10889981034115 ()

  • 4.5mm, 7mm
16-31-4507

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Occipital Screw, 6mm. 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
16-31-4506
Not in Commercial Distribution

  • 10889981034108 ()

  • 4.5mm, 6mm
16-31-4506

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