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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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Parallel Rod Connector, 3.5/3.5, Single
SEASPINE ORTHOPEDICS CORPORATION
50-0435
In Commercial Distribution

  • 10889981059071 ()

  • 3.5/3.5
50-0435

  • Vertebral body prosthesis, non-sterile
Parallel Rod Connector, 3.5/6.35, Double
SEASPINE ORTHOPEDICS CORPORATION
50-0335
In Commercial Distribution

  • 10889981059064 ()

  • 3.5/6.35
50-0335

  • Vertebral body prosthesis, non-sterile
Parallel Rod Connector, 3.5/5.5, Double
SEASPINE ORTHOPEDICS CORPORATION
50-0235
In Commercial Distribution

  • 10889981059057 ()

  • 3.5/5.5
50-0235

  • Vertebral body prosthesis, non-sterile
Parallel Rod Connector, 3.5/3.5, Double
SEASPINE ORTHOPEDICS CORPORATION
50-0135
In Commercial Distribution

  • 10889981059040 ()

  • 3.5/3.5
50-0135

  • Vertebral body prosthesis, non-sterile
Connector Set Screw
SEASPINE ORTHOPEDICS CORPORATION
50-0015
In Commercial Distribution

  • 10889981059033 ()
50-0015

  • Vertebral body prosthesis, non-sterile
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
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
4.5mm x 50mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-12-4550
In Commercial Distribution

  • 10889981053079 ()

  • 4.5mm x 50mm
16-12-4550

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm x 40mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-12-4540
In Commercial Distribution

  • 10889981053055 ()

  • 4.5mm x 40mm
16-12-4540

  • Bone-screw internal spinal fixation system, non-sterile
4.5mm x 26mm Poly Screw Assm. The Atoll OCT Spinal System is intended for use as an aid in spine fusion. It consists of screws, hooks, rods, and connectors. These components are available in a variety of sizes to allow for a variety of configurations to better fit each individual patient's pathology. The Atoll OCT Spinal System components are manufactured from medical implant grade titanium alloy Ti-6Al-4V (ELI) per ASTM F-136 or ISO 5832-3.
SEASPINE ORTHOPEDICS CORPORATION
16-12-4526
In Commercial Distribution

  • 10889981053017 ()

  • 4.5mm x 26mm
16-12-4526

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