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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 Device Size Type Device Class Implantable

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ROD, 5.5 X 110MM. The UCR system contains polyaxial screws of varying reduction height, rods, caps, set screws, crosslinks, crossbars and hooks. Implants are offered in a variety of lengths to accommodate variations in patient anatomy and are manufactured from Titanium 6Aluminum-4Vanadium ELI, with the exception of the Malibu and NewPort Cobalt 28Chromium-6Molybdenum component in the polyaxial screws and the Cobalt35Nickel-20Chromium-10Molybdenum alloy with lower inclusion counts used for some rods and wires.
SEASPINE ORTHOPEDICS CORPORATION
10-1011
In Commercial Distribution

  • 10889981028817 ()

  • 5.5mm X 110mm Rod
10-1011

  • Bone-screw internal spinal fixation system, non-sterile
LAMINAR 7.0 X 8.0 MM
SEASPINE ORTHOPEDICS CORPORATION
14-7080
In Commercial Distribution

  • 10889981036195 ()

  • 7.0 X 8.0 MM
14-7080

  • Bone-screw internal spinal fixation system, non-sterile
ROD, 5.5 X 450MM
SEASPINE ORTHOPEDICS CORPORATION
10-1045
In Commercial Distribution

  • 10889981029432 ()

  • 5.5mm X 450mm
10-1045

  • Bone-screw internal spinal fixation system, non-sterile
ROD, 5.5 X 250MM
SEASPINE ORTHOPEDICS CORPORATION
10-1025
In Commercial Distribution

  • 10889981029425 ()

  • 5.5mm X 250mm
10-1025

  • Bone-screw internal spinal fixation system, non-sterile
ROD, 5.5 X 90MM
SEASPINE ORTHOPEDICS CORPORATION
10-1009
In Commercial Distribution

  • 10889981029401 ()

  • 5.5mm X 90mm
10-1009

  • Bone-screw internal spinal fixation system, non-sterile
ROD, 5.5 X 70MM
SEASPINE ORTHOPEDICS CORPORATION
10-1007
In Commercial Distribution

  • 10889981029388 ()

  • 5.5mm X 70mm
10-1007

  • Bone-screw internal spinal fixation system, non-sterile
ROD, 5.5 X 60MM
SEASPINE ORTHOPEDICS CORPORATION
10-1006
In Commercial Distribution

  • 10889981029371 ()

  • 5.5mm X 60mm
10-1006

  • Bone-screw internal spinal fixation system, non-sterile
ROD, 5.5 X 50MM
SEASPINE ORTHOPEDICS CORPORATION
10-1005
In Commercial Distribution

  • 10889981029364 ()

  • 5.5mm X 50mm
10-1005

  • Bone-screw internal spinal fixation system, non-sterile
ROD, 5.5 X 35MM
SEASPINE ORTHOPEDICS CORPORATION
10-1003
In Commercial Distribution

  • 10889981029340 ()

  • 5.5mm X 35mm
10-1003

  • Bone-screw internal spinal fixation system, non-sterile
CROSSBAR, MEDIUM, 6.35 ROD
SEASPINE ORTHOPEDICS CORPORATION
11-3057
In Commercial Distribution

  • 10889981029326 ()

  • 6.35mm
11-3057

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