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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™ - 10889981052836

4.0mm x 34mm Smooth Shaft 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
16-13-4034
In Commercial Distribution

  • 10889981052836 ()

  • 4.0mm x 34mm
16-13-4034

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

Atoll™ - 10889981052829

4.0mm x 32mm Smooth Shaft 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
16-13-4032
In Commercial Distribution

  • 10889981052829 ()

  • 4.0mm x 32mm
16-13-4032

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

Atoll™ - 10889981052812

4.0mm x 30mm Smooth Shaft 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
16-13-4030
In Commercial Distribution

  • 10889981052812 ()

  • 4.0mm x 30mm
16-13-4030

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

Atoll™ - 10889981052805

4.0mm x 28mm Smooth Shaft 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
16-13-4028
In Commercial Distribution

  • 10889981052805 ()

  • 4.0mm x 28mm
16-13-4028

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

Atoll™ - 10889981052782

4.0mm x 24mm Smooth Shaft 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
16-13-4024
In Commercial Distribution

  • 10889981052782 ()

  • 4.0mm x 24mm
16-13-4024

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

Atoll™ - 10889981052775

4.0mm x 22mm Smooth Shaft 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
16-13-4022
In Commercial Distribution

  • 10889981052775 ()

  • 4.0mm x 22mm
16-13-4022

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

Malibu - 10889981011574

Cannulated Uni-Planar Screw 6.5 DIA x 25mm
SEASPINE ORTHOPEDICS CORPORATION
73-6525
Not in Commercial Distribution

  • 10889981011574 ()

  • 6.5 DIA x 25mm
73-6525

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

Malibu - 10889981011567

Cannulated Uni-Planar Screw 6.0 DIA x 110mm
SEASPINE ORTHOPEDICS CORPORATION
73-6510
Not in Commercial Distribution

  • 10889981011567 ()

  • 6.0 DIA x 110mm
73-6510

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

Malibu - 10889981011550

Cannulated Uni-Planar Screw 6.0 DIA x 105mm
SEASPINE ORTHOPEDICS CORPORATION
73-6505
Not in Commercial Distribution

  • 10889981011550 ()

  • 6.0 DIA x 105mm
73-6505

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

Malibu - 10889981011543

Cannulated Uni-Planar Screw 6.0 DIA x 100mm
SEASPINE ORTHOPEDICS CORPORATION
73-6500
Not in Commercial Distribution

  • 10889981011543 ()

  • 6.0 DIA x 100mm
73-6500

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