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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S2S CrossBar, 33 - 47mm. 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
50-2023
Not in Commercial Distribution

  • 10889910059165 ()

  • 33 - 47mm
50-2023

  • Vertebral body prosthesis, non-sterile
S2S CrossBar, 27 - 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
50-2022
Not in Commercial Distribution

  • 10889910059158 ()

  • 27 - 35mm
50-2022

  • Vertebral body prosthesis, non-sterile
S2S CrossBar, 24 - 29mm. 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
50-2021
Not in Commercial Distribution

  • 10889910059141 ()

  • 24 - 29mm
50-2021

  • Vertebral body prosthesis, non-sterile
Sierra Set Screw. 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
50-1005
Not in Commercial Distribution

  • 10889910059134 ()
50-1005

  • Vertebral body prosthesis, non-sterile
Sierra Extended Tab Screw, 04.5 x 50mm
SEASPINE ORTHOPEDICS CORPORATION
51-4550
Not in Commercial Distribution

  • 10889981044022 ()

  • 4.5 Dia X 50mm
51-4550

  • Cannulated surgical drill bit, single-use
Sierra Extended Tab Screw, 04.5 x 45mm
SEASPINE ORTHOPEDICS CORPORATION
51-4545
Not in Commercial Distribution

  • 10889981044015 ()

  • 4.5 Dia X 45mm
51-4545

  • Cannulated surgical drill bit, single-use
Sierra Extended Tab Screw, 04.5 x 40mm
SEASPINE ORTHOPEDICS CORPORATION
51-4540
Not in Commercial Distribution

  • 10889981044008 ()

  • 4.5 Dia X 40mm
51-4540

  • Cannulated surgical drill bit, single-use
Sierra Extended Tab Screw, 04.5 x 38mm
SEASPINE ORTHOPEDICS CORPORATION
51-4538
Not in Commercial Distribution

  • 10889981043995 ()

  • 4.5 Dia X 38mm
51-4538

  • Cannulated surgical drill bit, single-use
Sierra Extended Tab Screw, 04.5 x 36mm
SEASPINE ORTHOPEDICS CORPORATION
51-4536
Not in Commercial Distribution

  • 10889981043988 ()

  • 4.5 Dia X 36mm
51-4536

  • Cannulated surgical drill bit, single-use
Sierra Extended Tab Screw, 04.5 x 34mm
SEASPINE ORTHOPEDICS CORPORATION
51-4534
Not in Commercial Distribution

  • 10889981043971 ()

  • 4.5 Dia X 34mm
51-4534

  • Cannulated surgical drill bit, single-use
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