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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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 40MM
SEASPINE ORTHOPEDICS CORPORATION
10-1004
In Commercial Distribution

  • 10889981029357 ()

  • 5.5mm X 40mm
10-1004

  • 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, LARGE, 6.35 ROD
SEASPINE ORTHOPEDICS CORPORATION
11-3080
In Commercial Distribution

  • 10889981029333 ()

  • 6.35mm
11-3080

  • 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
CROSSBAR, SMALL, 6.35 ROD
SEASPINE ORTHOPEDICS CORPORATION
11-3045
In Commercial Distribution

  • 10889981029319 ()

  • 6.35mm
11-3045

  • Bone-screw internal spinal fixation system, non-sterile
CROSSBAR, XSMALL, 6.35 ROD
SEASPINE ORTHOPEDICS CORPORATION
11-3039
In Commercial Distribution

  • 10889981029302 ()

  • 6.35mm
11-3039

  • Bone-screw internal spinal fixation system, non-sterile
CROSSBAR, XXSMALL, 6.35 ROD
SEASPINE ORTHOPEDICS CORPORATION
11-3030
In Commercial Distribution

  • 10889981029296 ()

  • 6.35mm
11-3030

  • Bone-screw internal spinal fixation system, non-sterile
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
PEDICLE 9.0 X 5.0 MM
SEASPINE ORTHOPEDICS CORPORATION
14-9050
In Commercial Distribution

  • 10889981036201 ()

  • 9.0 X 5.0 MM
14-9050

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