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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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Clamshell 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
16-23-5530
In Commercial Distribution

  • 10889981033743 ()

  • 3.5mm to 5.5mm
16-23-5530

  • Bone-screw internal spinal fixation system, non-sterile
Offset 5.5mm to 3.5mm 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
16-23-5510
In Commercial Distribution

  • 10889981033729 ()

  • 5.5mm to 3.5mm
16-23-5510

  • Bone-screw internal spinal fixation system, non-sterile
Wedding Band 3.5mm to 3.5mm 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
16-23-3520
In Commercial Distribution

  • 10889981033705 ()

  • 3.5mm to 3.5mm
16-23-3520

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 80mm Pre-curved 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
16-18-1080
In Commercial Distribution

  • 10889981033682 ()

  • 3.5mm x 80mm
16-18-1080

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm Drill - Disposable
SEASPINE ORTHOPEDICS CORPORATION
16-40-0235
In Commercial Distribution

  • 10889981109202 ()

  • 3.5mm
16-40-0235

  • Orthopaedic implant driver
Bone Probe
SEASPINE ORTHOPEDICS CORPORATION
16-40-0101
In Commercial Distribution

  • 10889981109196 ()
16-40-0101

  • Neurosurgical probe
Awl
SEASPINE ORTHOPEDICS CORPORATION
16-40-0100
In Commercial Distribution

  • 10889981109189 ()
16-40-0100

  • Bone awl, reusable
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 Self Tapping Occipital Screw, 18mm. 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
16-32-4518
In Commercial Distribution

  • 10889981034481 ()

  • 4.5mm, 18mm
16-32-4518

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Self Tapping Occipital Screw, 13mm. 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
16-32-4513
In Commercial Distribution

  • 10889981034436 ()

  • 4.5mm, 13mm
16-32-4513

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