Stryker SERRATO. Lumbar Pedicle Screw System. ROD. Two-Level. Catalog #486615070

Vendor/Manufacturer: Stryker

Product/Product Line: SERRATO Rod

Vendor/Manufacturer Catalog #: 486615070

Global Unique Device (GUD) Primary Device Identifier Number: 07613154515080

Global Unique Device (GUD) Device Description:

TITANIUM RAD ROD

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Bone-screw internal spinal fixation system

Category 1: Spine

Category 2: Lumbar Pedicle Screw Systems

Category 3: Rod

Category 4: Two 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: NA

SUBSTANTIALLY EQUIVALENT to the following products:

1. NA