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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™ - 10889981042318

Closed Lateral Connector, 3.5 Rod. 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
50-0035
In Commercial Distribution

  • 10889981042318 ()

  • 3.5
50-0035

  • Cannulated surgical drill bit, single-use

BodyForm™ - 10889981057923

Thoracic Set Screw
SEASPINE ORTHOPEDICS CORPORATION
19-12-0001
In Commercial Distribution

  • 10889981057923 ()
19-12-0001

  • Spinal fixation plate, non-bioabsorbable

BodyForm™ - 10889981057916

Thoracic 60mm Bone Screw
SEASPINE ORTHOPEDICS CORPORATION
19-11-0060
In Commercial Distribution

  • 10889981057916 ()

  • 60mm
19-11-0060

  • Spinal fixation plate, non-bioabsorbable

BodyForm™ - 10889981057893

Thoracic 50mm Bone Screw
SEASPINE ORTHOPEDICS CORPORATION
19-11-0050
In Commercial Distribution

  • 10889981057893 ()

  • 50mm
19-11-0050

  • Spinal fixation plate, non-bioabsorbable

BodyForm™ - 10889981057879

Thoracic 40mm Bone Screw
SEASPINE ORTHOPEDICS CORPORATION
19-11-0040
In Commercial Distribution

  • 10889981057879 ()

  • 40mm
19-11-0040

  • Spinal fixation plate, non-bioabsorbable

BodyForm™ - 10889981057862

Thoracic 35mm Bone Screw
SEASPINE ORTHOPEDICS CORPORATION
19-11-0035
In Commercial Distribution

  • 10889981057862 ()

  • 35mm
19-11-0035

  • Spinal fixation plate, non-bioabsorbable

BodyForm™ - 10889981057855

Thoracic 30mm Bone Screw
SEASPINE ORTHOPEDICS CORPORATION
19-11-0030
In Commercial Distribution

  • 10889981057855 ()

  • 30mm
19-11-0030

  • Spinal fixation plate, non-bioabsorbable

BodyForm™ - 10889981057848

Thoracic 25mm Bone Screw
SEASPINE ORTHOPEDICS CORPORATION
19-11-0025
In Commercial Distribution

  • 10889981057848 ()

  • 25mm
19-11-0025

  • Spinal fixation plate, non-bioabsorbable

BodyForm™ - 10889981057824

Thoracic 99mm Plate
SEASPINE ORTHOPEDICS CORPORATION
19-10-0099
In Commercial Distribution

  • 10889981057824 ()

  • 99mm
19-10-0099

  • Spinal fixation plate, non-bioabsorbable

BodyForm™ - 10889981057817

Thoracic 95mm Plate
SEASPINE ORTHOPEDICS CORPORATION
19-10-0095
In Commercial Distribution

  • 10889981057817 ()

  • 95mm
19-10-0095

  • Spinal fixation plate, non-bioabsorbable
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