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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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
Reduction Screw Caddy
SEASPINE ORTHOPEDICS CORPORATION
MLBREDIMP
In Commercial Distribution

  • 10889981013134 ()
MLBREDIMP

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Monoaxial Instrument and Implant Tray
SEASPINE ORTHOPEDICS CORPORATION
MLBMIMP
In Commercial Distribution

  • 10889981013127 ()
MLBMIMP

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Implant Tray
SEASPINE ORTHOPEDICS CORPORATION
MLBIMP
In Commercial Distribution

  • 10889981013110 ()
MLBIMP

  • Bone-screw internal spinal fixation system, non-sterile
Malibu Deformity Implant
SEASPINE ORTHOPEDICS CORPORATION
MLBDFIMP
In Commercial Distribution

  • 10889981013103 ()
MLBDFIMP

  • Bone-screw internal spinal fixation system, non-sterile
Malibu 8.0 Implant
SEASPINE ORTHOPEDICS CORPORATION
MLB8IMP
In Commercial Distribution

  • 10889981013097 ()
MLB8IMP

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm Screw Caddy
SEASPINE ORTHOPEDICS CORPORATION
MLB45IMP
In Commercial Distribution

  • 10889981013080 ()
MLB45IMP

  • Bone-screw internal spinal fixation system, non-sterile
Dlta Screw Tray
SEASPINE ORTHOPEDICS CORPORATION
AOSSIMP
In Commercial Distribution

  • 10889981013059 ()
AOSSIMP

  • Bone-screw internal spinal fixation system, non-sterile
Locking Cannulated DLTA AO Driver, Short
SEASPINE ORTHOPEDICS CORPORATION
91-7253
In Commercial Distribution

  • 10889981083014 ()
91-7253

  • Orthopaedic implant driver
Tap 7.0mm, Modular (for 7.5mm Screw
SEASPINE ORTHOPEDICS CORPORATION
91-2187
In Commercial Distribution

  • 10889981081096 ()
91-2187

  • Bone tap, reusable
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