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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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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

Malibu™ - 10889981028138

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

Coral - 10889981028114

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

Coral - 10889981028107

CORAL® DEFORMITY IMPLANTS 1. 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
CORDEF2IMP
In Commercial Distribution

  • 10889981028107 ()
CORDEF2IMP

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

Coral - 10889981028091

Prebent Hex Rod 5.5 x 80mm. 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
18-30-0080
In Commercial Distribution

  • 10889981028091 ()

  • 5.5mm x 80mm Rod
18-30-0080

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

Coral - 10889981028084

Prebent Hex Rod 5.5 x 70mm. 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
18-30-0070
In Commercial Distribution

  • 10889981028084 ()

  • 5.5mm x 70mm Rod
18-30-0070

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

Coral - 10889981028077

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

Coral - 10889981028060

Prebent Hex Rod 5.5 x 50mm. 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
18-30-0050
In Commercial Distribution

  • 10889981028060 ()

  • 5.5mm x 50mm Rod
18-30-0050

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

Coral - 10889981028053

Prebent Hex Rod 5.5 x 45mm. 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
18-30-0045
In Commercial Distribution

  • 10889981028053 ()

  • 5.5mm x 45mm Rod
18-30-0045

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