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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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4.0mm Occipital Screw, 10mm. 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
16-31-4010
Not in Commercial Distribution

  • 10889981034016 ()

  • 4.0mm, 10mm
16-31-4010

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm Occipital Screw, 9mm. 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
16-31-4009
Not in Commercial Distribution

  • 10889981034009 ()

  • 4.0mm, 9mm
16-31-4009

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm Occipital Screw, 8mm. 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
16-31-4008
Not in Commercial Distribution

  • 10889981033996 ()

  • 4mm, 8mm
16-31-4008

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm 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
16-31-4007
Not in Commercial Distribution

  • 10889981033989 ()

  • 4.0mm,7mm
16-31-4007

  • Bone-screw internal spinal fixation system, non-sterile
Small Occipital Plate (25-35mm). 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
16-30-2535
In Commercial Distribution

  • 10889981033941 ()

  • small, 25-35mm
16-30-2535

  • Bone-screw internal spinal fixation system, non-sterile
Head - Head Connector. 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
16-22-1041
In Commercial Distribution

  • 10889981033910 ()

  • 41mm
16-22-1041

  • Bone-screw internal spinal fixation system, non-sterile
Arched Rod to Rod Cross Connector (55-65mm) 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
16-22-6555
In Commercial Distribution

  • 10889981033897 ()

  • 55-65mm
16-22-6555

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 120mm 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
16-18-0120
In Commercial Distribution

  • 10889981033804 ()

  • 3.5mm x 120mm
16-18-0120

  • Bone-screw internal spinal fixation system, non-sterile
Open Lateral Offset. 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
16-24-0020
In Commercial Distribution

  • 10889981033781 ()
16-24-0020

  • Bone-screw internal spinal fixation system, non-sterile
Closed Lateral Offset 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
16-24-0011
Not in Commercial Distribution

  • 10889981033774 ()
16-24-0011

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