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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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Stainless Steel - 10889981028237

Straight Rod, 150mm. The Stainless Steel Spinal System consists of a variety of types and sizes of rods, hooks, screws. The Stainless Steel Spinal System implant components can be rigidly locked into a variety of configurations that can be fit for the individual case. The Stainless Steel Spinal System uses components manufactured from 316 LVM stainless steel (ASTM F-138). Unless otherwise instructed, never use this product with components from another manufacturer or system.
SEASPINE ORTHOPEDICS CORPORATION
25-18-0150
In Commercial Distribution

  • 10889981028237 ()

  • 150mm Rod
25-18-0150

  • Vertebral body prosthesis, 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

Coral - 10889981028046

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

Coral - 10889981028039

Prebent Hex Rod 5.5 x 35mm. 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
18-30-0035
In Commercial Distribution

  • 10889981028039 ()

  • 5.5mm x 35mm Rod
18-30-0035

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