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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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NewPort - 10889981125547

NewPort Double Lead Screw, 4.75 x 45mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-4745
In Commercial Distribution

  • 10889981125547 ()

  • 4.75 x 45mm (4mm)
64-4745

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

NewPort - 10889981125530

NewPort Double Lead Screw, 4.75 x 40mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-4740
In Commercial Distribution

  • 10889981125530 ()

  • 4.75 x 40mm (4mm)
64-4740

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

NewPort - 10889981125523

NewPort Double Lead Screw, 4.75 x 35mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-4735
In Commercial Distribution

  • 10889981125523 ()

  • 4.75 x 35mm (4mm)
64-4735

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

NewPort - 10889981125516

NewPort Double Lead Screw, 4.75 x 30mm (4mm Hex)
SEASPINE ORTHOPEDICS CORPORATION
64-4730
In Commercial Distribution

  • 10889981125516 ()

  • 4.75 x 30mm (4mm)
64-4730

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

Malibu™ - 10889981028190

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

Malibu™ - 10889981028183

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

Malibu™ - 10889981028176

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

Malibu™ - 10889981028169

ANGLED HOOK, 5.5 X 6.5mm, 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 Cobaltt
SEASPINE ORTHOPEDICS CORPORATION
17-0565
In Commercial Distribution

  • 10889981028169 ()

  • 5.5 X 6.5mm, LEFT
17-0565

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

Malibu™ - 10889981028152

SCREW SPACER 7.0-7.5mmDIA X 2.5mm. 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
12-0325
In Commercial Distribution

  • 10889981028152 ()

  • 7.0-7.5mm DIA X 2.5mm
12-0325

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

Malibu™ - 10889981028145

SCREW SPACER 6.0-6.5mmDIA X 5.0mm. 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
12-0250
In Commercial Distribution

  • 10889981028145 ()

  • 6.0-6.5mm DIA X 5.0mm
12-0250

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