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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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Sierra™ - 10889981042714

Sierra Screw,4.5 Dia x 8mm. 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
50-4508
Not in Commercial Distribution

  • 10889981042714 ()

  • 4.5 Dia X 8mm
50-4508

  • Cannulated surgical drill bit, single-use

Sierra™ - 10889981042707

Sierra Screw, 04.0 x 40mm. 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
50-4040
Not in Commercial Distribution

  • 10889981042707 ()

  • 4.0 Dia X 40mm
50-4040

  • Cannulated surgical drill bit, single-use

UCR - 10889981062941

BULLET NOSE ROD, 5.5 x 150mm
SEASPINE ORTHOPEDICS CORPORATION
10-3150
In Commercial Distribution

  • 10889981062941 ()

  • 5.5 x 150mm
10-3150

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

Sierra™ - 10889981057640

Occipital Plate, 45-55mm. 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
50-8024
In Commercial Distribution

  • 10889981057640 ()

  • 45-55mm
50-8024

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889981057633

Occipital Plate, 40-50mm. 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
50-8023
In Commercial Distribution

  • 10889981057633 ()

  • 40-50mm
50-8023

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889981057619

Occipital Plate, 30-40mm. 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
50-8021
In Commercial Distribution

  • 10889981057619 ()

  • 30-40mm
50-8021

  • Vertebral body prosthesis, non-sterile

Sierra™ - 10889981057602

Occipital Plate, 25-35mm. 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
50-8020
In Commercial Distribution

  • 10889981057602 ()

  • 25-35mm
50-8020

  • Vertebral body prosthesis, non-sterile

Stainless Steel - 10889981114046

Malleable Rod, 400mm
SEASPINE ORTHOPEDICS CORPORATION
25-20-0400
In Commercial Distribution

  • 10889981114046 ()

  • 400mm
25-20-0400

  • Vertebral body prosthesis, non-sterile

Coral - 10889981110932

CoCr Prebent Rod 5.5 x 600mm
SEASPINE ORTHOPEDICS CORPORATION
18-21-0600
In Commercial Distribution

  • 10889981110932 ()

  • 5.5 X 600mm
18-21-0600

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

Coral - 10889981110260

CoCr Prebent Rod 5.5 x 25
SEASPINE ORTHOPEDICS CORPORATION
18-19-0025
In Commercial Distribution

  • 10889981110260 ()

  • 5.5 x 25
18-19-0025

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