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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™ - 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

Sierra™ - 10889981059149

S2S CrossBar, 24 - 29mm
SEASPINE ORTHOPEDICS CORPORATION
50-2021
In Commercial Distribution

  • 10889981059149 ()

  • 24 - 29mm
50-2021

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889981059132

Sierra Set Screw
SEASPINE ORTHOPEDICS CORPORATION
50-1005
In Commercial Distribution

  • 10889981059132 ()
50-1005

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889981059125

Axial Rod Connector, 3.5/6.35
SEASPINE ORTHOPEDICS CORPORATION
50-0935
In Commercial Distribution

  • 10889981059125 ()

  • 3.5/6.35
50-0935

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889981059118

Axial Rod Connector, 3.5/5.5
SEASPINE ORTHOPEDICS CORPORATION
50-0835
In Commercial Distribution

  • 10889981059118 ()

  • 3.5/5.5
50-0835

  • Vertebral body prosthesis, non-sterile
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