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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™ - 10889981028206

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

Mariner - 10889981138165

Torque Limiter Adaptor, 100in-lbs
SEASPINE ORTHOPEDICS CORPORATION
90-0705
In Commercial Distribution

  • 10889981138165 ()

  • 100in-lbs
90-0705

  • Vertebral body prosthesis, non-sterile

Malibu - 10889981028121

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

Laminoplasty - 10889981062637

Laminoplasty Optional Implant Set
SEASPINE ORTHOPEDICS CORPORATION
LAMNOPT
In Commercial Distribution

  • 10889981062637 ()
LAMNOPT

  • Vertebral body prosthesis, non-sterile

Laminoplasty - 10889981062620

Laminoplasty Implant Set
SEASPINE ORTHOPEDICS CORPORATION
LAMNIM
In Commercial Distribution

  • 10889981062620 ()
LAMNIM

  • Vertebral body prosthesis, non-sterile

Laminoplasty - 10889981062170

Lamina Sizing Trial, 6mm
SEASPINE ORTHOPEDICS CORPORATION
95-2406
In Commercial Distribution

  • 10889981062170 ()

  • 6mm L
95-2406

  • Vertebral body prosthesis, non-sterile

Laminoplasty - 10889981062163

Lamina Sizing Trial, 4mm
SEASPINE ORTHOPEDICS CORPORATION
95-2404
In Commercial Distribution

  • 10889981062163 ()

  • 4mm L
95-2404

  • Vertebral body prosthesis, non-sterile

Laminoplasty - 10889981062156

Plate Sizing Trial, 16mm L
SEASPINE ORTHOPEDICS CORPORATION
95-2316
In Commercial Distribution

  • 10889981062156 ()

  • 16mm L
95-2316

  • Vertebral body prosthesis, non-sterile

Laminoplasty - 10889981062149

Plate Sizing Trial, 14mm L
SEASPINE ORTHOPEDICS CORPORATION
95-2314
In Commercial Distribution

  • 10889981062149 ()

  • 14mm L
95-2314

  • Vertebral body prosthesis, non-sterile

Laminoplasty - 10889981062132

Plate Sizing Trial, 12mm L
SEASPINE ORTHOPEDICS CORPORATION
95-2312
In Commercial Distribution

  • 10889981062132 ()

  • 12mm L
95-2312

  • Vertebral body prosthesis, non-sterile
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