Depuy Synthes ANTEGRA Plate System. Catalog #04.102.141

Vendor/Manufacturer: Depuy Synthes

Product/Product Line: ANTEGRA Plate System

Vendor/Manufacturer Catalog #: 04.102.141

Global Unique Device (GUD) Primary Device Identifier Number: 

10705034733005

Global Unique Device (GUD) Device Description: 

TI ANTEGRA PLATE ONE LEVEL LUMBAR/41MM

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Bone-screw internal spinal fixation system, non-sterile

Global Medical Device Nomenclature (GMDN) Definition:

An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Category 1: Spine

Category 2: Thoracolumbar Plate and Screw System

Category 3: Plate

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3060

FDA Regulation Description Classification Name: 

Spinal intervertebral body fixation orthosis

FDA Classification Product Code: KWQ

FDA Classification Product Code Device Name: 

Appliance, Fixation, Spinal Intervertebral Body

FDA Premarket Submission: K063158

The Globus Medical PLYMOUTH Thoracolumbar Plate System is

SUBSTANTIALLY EQUIVALENT to the following products: 

1. Synthes Anterior Tension Band (ATB) System

SEARCH FOR THESE PRODUCTS

For more information, please visit us at Infonomics.com