Vendor/Manufacturer: Alphatec (Atec)
Product/Product Line: INVICTUS Screw
Vendor/Manufacturer Catalog #: 15025-065-045
Global Unique Device (GUD) Primary Device Identifier Number: 00190376117928
Global Unique Device (GUD) Device Description:
Cannulated Extended Tab Polyaxial Reduction Screw, 6.5 mm x 45 mm
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Bone-screw internal spinal fixation system, non-sterile
Category 1: Spine
Category 2: Lumbar Pedicle Screw Systems
Category 3: Screw
Category 4: One Level
Quantity of "Each"es needed in each System/Set: 4
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3070
FDA Regulation Description Classification Name:
Thoracolumbosacral pedicle screw system
FDA Classification Product Code: NKB
FDA Classification Product Code Device Name:
Thoracolumbosacral Pedicle Screw System
FDA Premarket Submissions: K181677
SUBSTANTIALLY EQUIVALENT to the following products:
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