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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™ - 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

Malibu - 10889981082062

Trial Rod, 4.8x600mm
SEASPINE ORTHOPEDICS CORPORATION
91-2984
In Commercial Distribution

  • 10889981082062 ()

  • 4.8x600mm
91-2984

  • Spinal implant trial

Malibu - 10889981082055

Trial Rod, 4.8 x 250mm
SEASPINE ORTHOPEDICS CORPORATION
91-2983
In Commercial Distribution

  • 10889981082055 ()

  • 4.8 x 250mm
91-2983

  • Spinal implant trial

Malibu - 10889981082048

Trial Rod, 4.8 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
91-2982
In Commercial Distribution

  • 10889981082048 ()

  • 4.8 x 110mm
91-2982

  • Spinal implant trial

Malibu - 10889981082031

Trial Rod, 4.8 x 60mm
SEASPINE ORTHOPEDICS CORPORATION
91-2981
In Commercial Distribution

  • 10889981082031 ()

  • 4.8 x 60mm
91-2981

  • Spinal implant trial

UCR - 10889981062941

BULLET NOSE ROD, 5.5 x 150mm
SEASPINE ORTHOPEDICS CORPORATION
10-3150
In Commercial Distribution

  • 10889981062941 ()

  • 5.5 x 150mm
10-3150

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

UCR - 10889981062699

CAP, 8MM
SEASPINE ORTHOPEDICS CORPORATION
10-0028
In Commercial Distribution

  • 10889981062699 ()

  • 8MM
10-0028

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

UCR - 10889981062682

CAP, 5.5/6.75
SEASPINE ORTHOPEDICS CORPORATION
10-0026
In Commercial Distribution

  • 10889981062682 ()

  • 5.5/6.75
10-0026

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