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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™ - 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™ - 10889981057626

Occipital Plate, 35-45mm. 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
50-8022
In Commercial Distribution

  • 10889981057626 ()

  • 35-45mm
50-8022

  • 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

Mariner - 10889981067571

Solid Screw 5.50 x 65mm
SEASPINE ORTHOPEDICS CORPORATION
41-5565-1
In Commercial Distribution

  • 10889981067571 ()

  • 5.50 x 65mm
41-5565-1

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

Mariner - 10889981067281

Cannulated Screw 5.00 x 80mm
SEASPINE ORTHOPEDICS CORPORATION
41-5080-2
In Commercial Distribution

  • 10889981067281 ()

  • 5.00 x 80mm
41-5080-2

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

Mariner - 10889981067021

Cannulated Screw 5.00 x 110mm
SEASPINE ORTHOPEDICS CORPORATION
41-5011-2
In Commercial Distribution

  • 10889981067021 ()

  • 5.00 x 110mm
41-5011-2

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

Mariner - 10889981067007

Cannulated Screw 5.00 x 100mm
SEASPINE ORTHOPEDICS CORPORATION
41-5010-2
In Commercial Distribution

  • 10889981067007 ()

  • 5.00 x 100mm
41-5010-2

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

Mariner - 10889981066970

Deformity Seat
SEASPINE ORTHOPEDICS CORPORATION
41-5000
In Commercial Distribution

  • 10889981066970 ()
41-5000

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

Mariner - 10889981066956

Solid Screw 4.75 x 95mm
SEASPINE ORTHOPEDICS CORPORATION
41-4795-1
In Commercial Distribution

  • 10889981066956 ()

  • 4.75 x 95mm
41-4795-1

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

Mariner - 10889981066932

Solid Screw 4.75 x 90mm
SEASPINE ORTHOPEDICS CORPORATION
41-4790-1
In Commercial Distribution

  • 10889981066932 ()

  • 4.75 x 90mm
41-4790-1

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