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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 Deployer 2 Implant. The NewPort system contains cannulated polyaxial screws, locking caps and rods. Additionally, the NewPort system may be implanted using either minimally-invasive/percutaneous techniques or conventional surgical methods; manual instrumentation is available for both approaches. 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
NWD2IMP
In Commercial Distribution

  • 10889981028206 ()
NWD2IMP

  • Vertebral body prosthesis, 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
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
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
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
SCREW SPACER 4.5-8.5MM X 3.0MM. 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
12-0143
In Commercial Distribution

  • 10889981028138 ()

  • 4.5-8.5MM X 3.0MM
12-0143

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Deformity Hook Implant. 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
MLBDHIMP
In Commercial Distribution

  • 10889981028121 ()
MLBDHIMP

  • Vertebral body prosthesis, non-sterile
ATOLL™ CORAL®TRANSITION SET. The Coral Spinal System consists of a variety of types and sizes of rods, hooks, screws, and connectors. The Coral Spinal System implant components can be rigidly locked into a variety of configurations that can be fit for the individual case. The Coral Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136, ASTM-F-67, and cobalt chrome alloy per ASTM F-1537.
SEASPINE ORTHOPEDICS CORPORATION
TRANSIMP
In Commercial Distribution

  • 10889981028114 ()
TRANSIMP

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