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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 Type Device Class Implantable

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Atoll™ - 10889981052577

4.0mm x 28mm 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
16-12-4028
In Commercial Distribution

  • 10889981052577 ()

  • 4.0mm x 28mm
16-12-4028

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

Atoll™ - 10889981052553

4.0mm x 24mm 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
16-12-4024
In Commercial Distribution

  • 10889981052553 ()

  • 4.0mm x 24mm
16-12-4024

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

Atoll™ - 10889981052539

4.0mm x 20mm 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
16-12-4020
In Commercial Distribution

  • 10889981052539 ()

  • 4.0mm x 20mm
16-12-4020

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

Atoll™ - 10889981052232

4.0mm 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
16-10-4014
In Commercial Distribution

  • 10889981052232 ()

  • 4.0mm x 14mm
16-10-4014

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

Atoll™ - 10889981052218

4.0mm 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
16-10-4010
Not in Commercial Distribution

  • 10889981052218 ()

  • 4.0mm x 10mm
16-10-4010

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

Atoll™ - 10889981052195

3.5mm 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
16-10-3528
In Commercial Distribution

  • 10889981052195 ()

  • 3.5mm x 28mm
16-10-3528

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

Atoll™ - 10889981052188

3.5mm x 26mm 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
16-10-3526
Not in Commercial Distribution

  • 10889981052188 ()

  • 3.5mm x 26mm
16-10-3526

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

Atoll™ - 10889981052171

3.5mm 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
16-10-3524
Not in Commercial Distribution

  • 10889981052171 ()

  • 3.5mm x 24mm
16-10-3524

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

Stainless Steel - 10889981028435

Supra-Laminar Angled Hook Medium. The Stainless Steel Spinal System consists of a variety of types and sizes of rods, hooks, screws. The Stainless Steel Spinal System implant components can be rigidly locked into a variety of configurations that can be fit for the individual case. The Stainless Steel Spinal System uses components manufactured from 316 LVM stainless steel (ASTM F-138). Unless otherwise instructed, never use this product with components from another manufacturer or system.
SEASPINE ORTHOPEDICS CORPORATION
25-21-1207
In Commercial Distribution

  • 10889981028435 ()
25-21-1207

  • Vertebral body prosthesis, non-sterile

Stainless Steel - 10889981028411

Extended Lamina Hook Large. The Stainless Steel Spinal System consists of a variety of types and sizes of rods, hooks, screws. The Stainless Steel Spinal System implant components can be rigidly locked into a variety of configurations that can be fit for the individual case. The Stainless Steel Spinal System uses components manufactured from 316 LVM stainless steel (ASTM F-138). Unless otherwise instructed, never use this product with components from another manufacturer or system.
SEASPINE ORTHOPEDICS CORPORATION
25-21-1009
In Commercial Distribution

  • 10889981028411 ()
25-21-1009

  • Vertebral body prosthesis, non-sterile
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