Alphatec (Atec) INVICTUS. Lumbar Pedicle Screw System. ROD. One-Level. Catalog #15230-55-040
- CataBlog
- Dec 11, 2020
- 1 min read
Vendor/Manufacturer: Alphatec (Atec)
Product/Product Line: INVICTUS Rod
Vendor/Manufacturer Catalog #: 15230-55-040
Global Unique Device (GUD) Primary Device Identifier Number: 00190376139159
Global Unique Device (GUD) Device Description:
Ti MIS Lordotic Rod, 5.5 mm x 40 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: Rod
Category 4: One Level
Quantity of "Each"es needed in each System/Set: 2
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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