Stryker SERRATO. Lumbar Pedicle Screw System. BLOCKER. One-Level. Catalog #48230000

Vendor/Manufacturer: Stryker Product/Product Line: SERRATO Blocker Vendor/Manufacturer Catalog #: 48230000 Global Unique Device (GUD) Primary Device Identifier Number: 04546540560193 Global Unique Device (GUD) Device Description: BLOCKER 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: Blocker 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: NA SUBSTANTIALLY EQUIVALENT to the following products: 1. NA