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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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4.5mm x 12mm 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
16-12-4512
In Commercial Distribution

  • 10889981052942 ()

  • 4.5mm x 12mm
16-12-4512

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm x 10mm 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
16-12-4510
In Commercial Distribution

  • 10889981052935 ()

  • 4.5mm x 10mm
16-12-4510

  • Bone-screw internal spinal fixation system, non-sterile
3.5mm x 16mm 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
16-12-3516
In Commercial Distribution

  • 10889981052355 ()

  • 3.5mm x 16mm
16-12-3516

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm 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
16-10-4028
In Commercial Distribution

  • 10889981052300 ()

  • 4.0mm x 28mm
16-10-4028

  • Bone-screw internal spinal fixation system, non-sterile
4.0mm 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
16-10-4024
In Commercial Distribution

  • 10889981052287 ()

  • 4.0mm x 24mm
16-10-4024

  • Bone-screw internal spinal fixation system, non-sterile
Modified Angled Driver
SEASPINE ORTHOPEDICS CORPORATION
SR-0212
In Commercial Distribution

  • 10889981160180 ()
SR-0212

  • Orthopaedic implant driver
Modified Screw/Hook Inserter
SEASPINE ORTHOPEDICS CORPORATION
SR-0207
In Commercial Distribution

  • 10889981153861 ()
SR-0207

  • Orthopaedic implant inserter/extractor, reusable
Balboa Mixed Implant Caddy
SEASPINE ORTHOPEDICS CORPORATION
91-9503
In Commercial Distribution

  • 10889981086596 ()
91-9503

  • Instrument tray, reusable
Balboa Implant Caddy
SEASPINE ORTHOPEDICS CORPORATION
91-9502
In Commercial Distribution

  • 10889981086589 ()
91-9502

  • Instrument tray, reusable
Balboa Sterilization Tray
SEASPINE ORTHOPEDICS CORPORATION
91-9501
In Commercial Distribution

  • 10889981086572 ()
91-9501

  • Instrument tray, reusable
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