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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 Device Size Type Device Class Implantable

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Axial Rod Connector, 3.5/5.5. 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
50-0835
Not in Commercial Distribution

  • 10889910059110 ()

  • 3.5/5.5
50-0835

  • Vertebral body prosthesis, non-sterile
Axial Rod Connector, 3.5/3.5. 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
50-0735
Not in Commercial Distribution

  • 10889910059103 ()

  • 3.5/3.5
50-0735

  • Vertebral body prosthesis, non-sterile
Parallel Rod Connector, 3.5/6.35, Single. 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
50-0635
Not in Commercial Distribution

  • 10889910059097 ()

  • 3.5/6.35
50-0635

  • Vertebral body prosthesis, non-sterile
Parallel Rod Connector, 3.5/3.5, Single. 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
50-0435
Not in Commercial Distribution

  • 10889910059073 ()

  • 3.5/3.5
50-0435

  • Vertebral body prosthesis, non-sterile
Parallel Rod Connector, 3.5/5.5, Double. 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
50-0235
Not in Commercial Distribution

  • 10889910059059 ()

  • 3.5/5.5
50-0235

  • Vertebral body prosthesis, non-sterile
Cambria Rasp, 13 x 12 x 10mm, w/Depth Stop, Flat
SEASPINE ORTHOPEDICS CORPORATION
93-9820
In Commercial Distribution

  • 10889981093761 ()

  • 13 x 12 x 10mm
93-9820

  • Bone file/rasp, manual, reusable
Cambria Rasp, 13 x 12 x 9mm, w/Depth Stop, Flat
SEASPINE ORTHOPEDICS CORPORATION
93-9819
In Commercial Distribution

  • 10889981093754 ()

  • 13 x 12 x 9mm
93-9819

  • Bone file/rasp, manual, reusable
Cambria Rasp, 13 x 12 x 8mm, w/Depth Stop, Flat
SEASPINE ORTHOPEDICS CORPORATION
93-9818
In Commercial Distribution

  • 10889981093747 ()

  • 13 x 12 x 8mm
93-9818

  • Bone file/rasp, manual, reusable
Cambria Rasp, 13 x 12 x 7mm, w/Depth Stop, Flat
SEASPINE ORTHOPEDICS CORPORATION
93-9817
In Commercial Distribution

  • 10889981093730 ()

  • 13 x 12 x 7mm
93-9817

  • Bone file/rasp, manual, reusable
Cambria Rasp, 13 x 12 x 6mm, w/Depth Stop, Flat
SEASPINE ORTHOPEDICS CORPORATION
93-9816
In Commercial Distribution

  • 10889981093723 ()

  • 13 x 12 x 6mm
93-9816

  • Bone file/rasp, manual, reusable
Cambria Rasp, 13 x 12 x 5mm, w/Depth Stop, Flat
SEASPINE ORTHOPEDICS CORPORATION
93-9815
In Commercial Distribution

  • 10889981093716 ()

  • 13 x 12 x 5mm
93-9815

  • Bone file/rasp, manual, reusable
Cambria Rasp, 13 x 12 x 12mm, w/Depth Stop
SEASPINE ORTHOPEDICS CORPORATION
93-9812
In Commercial Distribution

  • 10889981093709 ()

  • 13 x 12 x 12mm
93-9812

  • Bone file/rasp, manual, reusable
Cambria Rasp, 13 x 12 x 11mm, w/Depth Stop
SEASPINE ORTHOPEDICS CORPORATION
93-9811
In Commercial Distribution

  • 10889981093693 ()

  • 13 x 12 x 11mm
93-9811

  • Bone file/rasp, manual, reusable
Cambria Rasp, 13 x 12 x 10mm, w/Depth Stop
SEASPINE ORTHOPEDICS CORPORATION
93-9810
In Commercial Distribution

  • 10889981093686 ()

  • 13 x 12 x 10mm
93-9810

  • Bone file/rasp, manual, reusable
Cambria Rasp, 13 x 12 x 9mm, w/Depth Stop
SEASPINE ORTHOPEDICS CORPORATION
93-9809
In Commercial Distribution

  • 10889981093679 ()

  • 13 x 12 x 9mm
93-9809

  • Bone file/rasp, manual, reusable
Cambria Rasp, 13 x 12 x 8mm, w/Depth Stop
SEASPINE ORTHOPEDICS CORPORATION
93-9808
In Commercial Distribution

  • 10889981093662 ()

  • 13 x 12 x 8mm
93-9808

  • Bone file/rasp, manual, reusable
Cambria Rasp, 13 x 12 x 7mm, w/Depth Stop
SEASPINE ORTHOPEDICS CORPORATION
93-9807
In Commercial Distribution

  • 10889981093655 ()

  • 13 x 12 x 7mm
93-9807

  • Bone file/rasp, manual, reusable
Cambria Rasp, 13 x 12 x 6mm, w/Depth Stop
SEASPINE ORTHOPEDICS CORPORATION
93-9806
In Commercial Distribution

  • 10889981093648 ()

  • 13 x 12 x 6mm
93-9806

  • Bone file/rasp, manual, reusable
Cambria Rasp, 13 x 12 x 5mm, w/Depth Stop
SEASPINE ORTHOPEDICS CORPORATION
93-9805
In Commercial Distribution

  • 10889981093631 ()

  • 13 x 12 x 5mm
93-9805

  • Bone file/rasp, manual, reusable
Cambria Rasp, 15 x 13 x 12mm, w/Depth Stop
SEASPINE ORTHOPEDICS CORPORATION
93-9742
In Commercial Distribution

  • 10889981093624 ()

  • 15 x 13 x 12mm
93-9742

  • Bone file/rasp, manual, reusable
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