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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™ - 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

Coral - 10889981110253

CoCr Prebent Rod 5.5 x 20
SEASPINE ORTHOPEDICS CORPORATION
18-19-0020
In Commercial Distribution

  • 10889981110253 ()

  • 5.5 x 20
18-19-0020

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

Coral - 10889981110239

CoCr Str. Rod 5.5 x 400
SEASPINE ORTHOPEDICS CORPORATION
18-18-0400
In Commercial Distribution

  • 10889981110239 ()

  • 5.5 x 400
18-18-0400

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

Coral - 10889981105440

Hex-End Straight Rod 5.5 x 600
SEASPINE ORTHOPEDICS CORPORATION
10-25-0600
In Commercial Distribution

  • 10889981105440 ()

  • 5.5 x 600
10-25-0600

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

Coral - 10889981105280

Hex-End Straight Rod 5.5 x 230
SEASPINE ORTHOPEDICS CORPORATION
10-25-0230
In Commercial Distribution

  • 10889981105280 ()

  • 5.5 x 230
10-25-0230

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