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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, 14mm. 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
16-31-4014
Not in Commercial Distribution

  • 10889981034054 ()

  • 4.0mm, 14mm
16-31-4014

  • 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
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
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
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
16-22-1034
In Commercial Distribution

  • 10889981033903 ()

  • 34mm
16-22-1034

  • 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
Arched Rod to Rod Cross Connector(55-45mm) 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
16-22-5545
In Commercial Distribution

  • 10889981033880 ()

  • 55-45mm
16-22-5545

  • Bone-screw internal spinal fixation system, non-sterile
Arched Rod to Rod Cross Connector(45-35mm) 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
16-22-4535
In Commercial Distribution

  • 10889981033873 ()

  • 45-35mm
16-22-4535

  • Bone-screw internal spinal fixation system, non-sterile
Offset Hook (left) - 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
16-21-1805
In Commercial Distribution

  • 10889981033842 ()

  • medium
16-21-1805

  • Bone-screw internal spinal fixation system, non-sterile
Inline Hook - 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
16-21-0205
In Commercial Distribution

  • 10889981033828 ()

  • medium
16-21-0205

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