Stryker SERRATO. Lumbar Pedicle Screw System. BLOCKER. Two-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: Two Level

Quantity of "Each"es needed in each System/Set: 6

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