Renovis S100 Pedicle Screw System. Polyaxial SCREW. Two-Level. Catalog #1111-653-045

Vendor/Manufacturer: Renovis Surgical Technologies

Product/Product Line: Renovis S100 Polyaxial SCREW 6.5mm x 45mm

Vendor/Manufacturer Catalog #: 1111-653-045

Global Unique Device (GUD) Primary Device Identifier Number: 00841523108527

Global Unique Device (GUD) Device Description:

Polyaxial Screw 6.5mm diameter 45mm length for use with a 5.5mm Rod

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: 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:

Pedicle Screw Spinal System

FDA Classification Product Code: NKB

FDA Classification Product Code Device Name:

Thoracolumbosacral Pedicle Screw System

SUBSTANTIALLY EQUIVALENT to the following products:

1. NA