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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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Straight Rod 5.5 x 40
SEASPINE ORTHOPEDICS CORPORATION
10-18-0040
In Commercial Distribution

  • 10889981028855 ()

  • 5.5mm x 40mm
10-18-0040

  • Bone-screw internal spinal fixation system, non-sterile
Straight Rod 5.5 x 35
SEASPINE ORTHOPEDICS CORPORATION
10-18-0035
In Commercial Distribution

  • 10889981028848 ()

  • 5.5mm x 35mm
10-18-0035

  • Bone-screw internal spinal fixation system, non-sterile
Straight Rod 5.5 x 30
SEASPINE ORTHOPEDICS CORPORATION
10-18-0030
In Commercial Distribution

  • 10889981028831 ()

  • 5.5mm x 30mm
10-18-0030

  • Bone-screw internal spinal fixation system, non-sterile
Straight Rod 5.5 x 25
SEASPINE ORTHOPEDICS CORPORATION
10-18-0025
In Commercial Distribution

  • 10889981028824 ()

  • 5.5mm x 25mm
10-18-0025

  • 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
OFFSET HOOK 5.5 X 9.5mm RIGHT. The Malibu system contains polyaxial screws of varying reduction height, cannulated polyaxial screws of varying reduction height, uniplanar screws of varying reduction height, monoaxial screws, iliac onoaxial screws, rods, rod connectors, screw spacers, crossbars, sublaminar wires 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.
SEASPINE ORTHOPEDICS CORPORATION
17-3595
In Commercial Distribution

  • 10889981028190 ()

  • 5.5mm X 9.5mm
17-3595

  • Bone-screw internal spinal fixation system, non-sterile
OFFSET HOOK 5.5 X 9.5mm LEFT. The Malibu system contains polyaxial screws of varying reduction height, cannulated polyaxial screws of varying reduction height, uniplanar screws of varying reduction height, monoaxial screws, iliac onoaxial screws, rods, rod connectors, screw spacers, crossbars, sublaminar wires 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.
SEASPINE ORTHOPEDICS CORPORATION
17-2595
In Commercial Distribution

  • 10889981028183 ()

  • 5.5mm X 9.5mm
17-2595

  • Bone-screw internal spinal fixation system, non-sterile
ANGLED HOOK, 5.5 X 6.5mm, RIGHT. The Malibu system contains polyaxial screws of varying reduction height, cannulated polyaxial screws of varying reduction height, uniplanar screws of varying reduction height, monoaxial screws, iliac onoaxial screws, rods, rod connectors, screw spacers, crossbars, sublaminar wires 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.
SEASPINE ORTHOPEDICS CORPORATION
17-1565
In Commercial Distribution

  • 10889981028176 ()

  • 5.5 X 6.5mm, RIGHT
17-1565

  • Bone-screw internal spinal fixation system, non-sterile
D-Planar Screw, 8.50mm x 80mm
SEASPINE ORTHOPEDICS CORPORATION
25-15-8580
Not in Commercial Distribution

  • 10889981024697 ()

  • 8.50mm x 80mm
25-15-8580

  • Bone-screw internal spinal fixation system, non-sterile
D-Planar Screw, 8.50mm x 75mm
SEASPINE ORTHOPEDICS CORPORATION
25-15-8575
Not in Commercial Distribution

  • 10889981024680 ()

  • 8.50mm x 75mm
25-15-8575

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