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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™ - 10889981052300

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

Atoll™ - 10889981052287

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

Sierra™ - 10889981059156

S2S CrossBar, 27 - 35mm
SEASPINE ORTHOPEDICS CORPORATION
50-2022
In Commercial Distribution

  • 10889981059156 ()

  • 27 - 35mm
50-2022

  • 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™ - 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

Sierra™ - 10889981059057

Parallel Rod Connector, 3.5/5.5, Double
SEASPINE ORTHOPEDICS CORPORATION
50-0235
In Commercial Distribution

  • 10889981059057 ()

  • 3.5/5.5
50-0235

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889981059040

Parallel Rod Connector, 3.5/3.5, Double
SEASPINE ORTHOPEDICS CORPORATION
50-0135
In Commercial Distribution

  • 10889981059040 ()

  • 3.5/3.5
50-0135

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889981059033

Connector Set Screw
SEASPINE ORTHOPEDICS CORPORATION
50-0015
In Commercial Distribution

  • 10889981059033 ()
50-0015

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889981059163

S2S CrossBar, 33 - 47mm
SEASPINE ORTHOPEDICS CORPORATION
50-2023
In Commercial Distribution

  • 10889981059163 ()

  • 33 - 47mm
50-2023

  • Vertebral body prosthesis, 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
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