Renovis S100 Pedicle Screw System. ROD. Two-Level. Catalog #: 1101-053-070

Vendor/Manufacturer: Renovis Surgical Technologies

Product/Product Line: Renovis S100 ROD 5.5mm X 70 mm

Vendor/Manufacturer Catalog #: 1101-053-070

Global Unique Device (GUD) Primary Device Identifier Number: 00841523106929

Global Unique Device (GUD) Device Description:

Pre Lordosed Rod 5.5mm diameter 70mm length Ti6A14V

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: 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:

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