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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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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
NewPort Rod Implant. The NewPort system contains cannulated polyaxial screws, locking caps and rods. Additionally, the NewPort system may be implanted using either minimally-invasive/percutaneous techniques or conventional surgical methods; manual instrumentation is available for both approaches. 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
NWPRIMP
In Commercial Distribution

  • 10889981028220 ()
NWPRIMP

  • Vertebral body prosthesis, non-sterile
NewPort Extended Rod Caddy BOM. The NewPort system contains cannulated polyaxial screws, locking caps and rods. Additionally, the NewPort system may be implanted using either minimally-invasive/percutaneous techniques or conventional surgical methods; manual instrumentation is available for both approaches. 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
NWPEXRIMP
In Commercial Distribution

  • 10889981028213 ()
NWPEXRIMP

  • Vertebral body prosthesis, non-sterile
NewPort Deployer 2 Implant. The NewPort system contains cannulated polyaxial screws, locking caps and rods. Additionally, the NewPort system may be implanted using either minimally-invasive/percutaneous techniques or conventional surgical methods; manual instrumentation is available for both approaches. 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
NWD2IMP
In Commercial Distribution

  • 10889981028206 ()
NWD2IMP

  • Vertebral body prosthesis, non-sterile
Malibu Deformity Hook Implant. 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
MLBDHIMP
In Commercial Distribution

  • 10889981028121 ()
MLBDHIMP

  • Vertebral body prosthesis, non-sterile
Cambria NM Implant, 13x12, 5mm, Flat, Lordotic
SEASPINE ORTHOPEDICS CORPORATION
39-2405
In Commercial Distribution

  • 10889981064839 ()

  • 13x12, 5mm
39-2405

  • Vertebral body prosthesis, non-sterile
Sierra Screw, 04.0 x 38mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-4038
Not in Commercial Distribution

  • 10889981042691 ()

  • 4.0 Dia X 38mm
50-4038

  • Cannulated surgical drill bit, single-use
Sierra Screw, 04.0 x 36mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-4036
Not in Commercial Distribution

  • 10889981042684 ()

  • 4.0 Dia X 36mm
50-4036

  • Cannulated surgical drill bit, single-use
Sierra Screw, 04.0 x 34mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-4034
Not in Commercial Distribution

  • 10889981042677 ()

  • 4.0 Dia X 34mm
50-4034

  • Cannulated surgical drill bit, single-use
Sierra Screw, 04.0 x 32mm. The Sierra occipito-cervico-thoracic (OCT) spinal fixation system, including polyaxial screws, rods, locking caps, occipital plates, occipital screws, lateral connectors, contoured crossbars, hooks, and components, is used to provide stabilization of the spine in order to permit the biological process of spinal fusion to occur. Accepted standard techniques of spinal fusion are an integral part of the implantation of this system.
SEASPINE ORTHOPEDICS CORPORATION
50-4032
Not in Commercial Distribution

  • 10889981042660 ()

  • 4.0 Dia X 32mm
50-4032

  • Cannulated surgical drill bit, single-use
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