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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 Left Small. 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
25-21-1604-L
In Commercial Distribution

  • 10889981028473 ()
25-21-1604-L

  • Vertebral body prosthesis, non-sterile
Transverse Process Hook Medium. 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
25-21-1407
In Commercial Distribution

  • 10889981028466 ()
25-21-1407

  • Vertebral body prosthesis, non-sterile
Supra-Laminar Angled Hook Medium. 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
25-21-1207
In Commercial Distribution

  • 10889981028435 ()
25-21-1207

  • Vertebral body prosthesis, non-sterile
Pedicle Hook Medium. 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
25-21-0207
In Commercial Distribution

  • 10889981028329 ()
25-21-0207

  • Vertebral body prosthesis, non-sterile
Malleable Rod, 600mm. 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
25-20-0600
In Commercial Distribution

  • 10889981028305 ()

  • 600mm Rod
25-20-0600

  • Vertebral body prosthesis, non-sterile
Malleable Rod, 500mm. 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
25-20-0500
In Commercial Distribution

  • 10889981028299 ()

  • 500mm Rod
25-20-0500

  • Vertebral body prosthesis, non-sterile
Straight Rod, 600mm. 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
25-18-0600
In Commercial Distribution

  • 10889981028275 ()

  • 600mm Rod
25-18-0600

  • Vertebral body prosthesis, non-sterile
Straight Rod, 500mm. 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
25-18-0500
In Commercial Distribution

  • 10889981028268 ()

  • 500mm Rod
25-18-0500

  • Vertebral body prosthesis, non-sterile
Straight Rod, 400mm. 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
25-18-0400
In Commercial Distribution

  • 10889981028251 ()

  • 400mm Rod
25-18-0400

  • Vertebral body prosthesis, non-sterile
OFFSET HOOK 5.5 X 9.5mm RIGHT. 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
17-3595
In Commercial Distribution

  • 10889981028190 ()

  • 5.5mm X 9.5mm
17-3595

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