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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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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
Prebent Hex Rod 5.5 x 60mm. 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
18-30-0060
In Commercial Distribution

  • 10889981028077 ()

  • 5.5mm x 60mm Rod
18-30-0060

  • Bone-screw internal spinal fixation system, non-sterile
Prebent Hex Rod 5.5 x 40mm. 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
18-30-0040
In Commercial Distribution

  • 10889981028046 ()

  • 5.5mm x 40mm Rod
18-30-0040

  • Bone-screw internal spinal fixation system, non-sterile
CoCr Hex-End Straight Rod 5.5 x 600. 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
18-20-0600
In Commercial Distribution

  • 10889981028022 ()

  • 5.5mm x 600mm Rod
18-20-0600

  • Bone-screw internal spinal fixation system, non-sterile
CoCr Hex-End Straight Rod 5.5 x 500. 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
18-20-0500
In Commercial Distribution

  • 10889981028015 ()

  • 5.5mm x 500mm Rod
18-20-0500

  • Bone-screw internal spinal fixation system, non-sterile
CoCr Hex-End Straight Rod 5.5 x 450. 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
18-20-0450
In Commercial Distribution

  • 10889981028008 ()

  • 5.5mm x 450mm Rod
18-20-0450

  • Bone-screw internal spinal fixation system, non-sterile
CoCr Hex-End Straight Rod 5.5 x 200. 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
18-20-0200
In Commercial Distribution

  • 10889981027988 ()

  • 5.5mm x 200mm Rod
18-20-0200

  • Bone-screw internal spinal fixation system, non-sterile
CoCr Str. Rod 5.5 x 600. 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
18-18-0600
In Commercial Distribution

  • 10889981027971 ()

  • 5.5mm x 600mm Rod
18-18-0600

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