DePuy Synthes SYNFIX® EVOLUTION Interbody Fusion. Catalog #08.815.223S

CataBlog
Dec 19, 2020
1 min read

Updated: May 12, 2024

Vendor/Manufacturer: DePuy Synthes

Product/Product Line: SYNFIX® EVOLUTION Interbody Fusion

Vendor/Manufacturer Catalog #: 08.815.223S

Global Unique Device (GUD) Primary Device Identifier Number:

10705034815404

Global Unique Device (GUD) Device Description:

SYNFIX® EVOLUTION SPACER MED/13.5MM HEIGHT/14°-STERILE

Category 1: Spine

Category 2: Interbody Fusion Devices

Category 3: Lumbar/T-Lumbar

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Polymeric spinal interbody fusion cage

Global Medical Device Nomenclature (GMDN) Definition:

A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

FDA Regulation Medical Specialty:

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3080

FDA Regulation Description Classification Name:

Intervertebral body fusion device

FDA Classification Product Code(s): OVD

FDA Classification Product Code Device Name:

Intervertebral fusion device with integrated fixation, lumbar

FDA Premarket Submissions: K162358, K150673

The DePuy Synthes SYNFIX® EVOLUTION Interbody Fusion Device is

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. NuVasive Interfixated Interbody System