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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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Atoll™ - 10889981052157

3.5mm x 20mm 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
16-10-3520
In Commercial Distribution

  • 10889981052157 ()

  • 3.5mm x 20mm
16-10-3520

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

Atoll™ - 10889981052140

3.5mm x 18mm 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
16-10-3518
Not in Commercial Distribution

  • 10889981052140 ()

  • 3.5mm x 18mm
16-10-3518

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

Atoll™ - 10889981052133

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

Atoll™ - 10889981052126

3.5mm x 14mm 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
16-10-3514
In Commercial Distribution

  • 10889981052126 ()

  • 3.5mm x 14mm
16-10-3514

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

Atoll™ - 10889981052119

3.5mm x 12mm 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
16-10-3512
In Commercial Distribution

  • 10889981052119 ()

  • 3.5mm x 12mm
16-10-3512

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

Atoll™ - 10889981052102

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

Atoll™ - 10889981052096

3.5mm x 8mm 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
16-10-3508
In Commercial Distribution

  • 10889981052096 ()

  • 3.5mm x 8mm
16-10-3508

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

Atoll™ - 10889981053079

4.5mm x 50mm 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
16-12-4550
In Commercial Distribution

  • 10889981053079 ()

  • 4.5mm x 50mm
16-12-4550

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

Atoll™ - 10889981053062

4.5mm x 45mm 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
16-12-4545
In Commercial Distribution

  • 10889981053062 ()

  • 4.5mm x 45mm
16-12-4545

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

Atoll™ - 10889981053055

4.5mm x 40mm 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
16-12-4540
In Commercial Distribution

  • 10889981053055 ()

  • 4.5mm x 40mm
16-12-4540

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