DePuy Synthes SYNFIX® EVOLUTION Interbody Fusion. Catalog #04.835.125.02S

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 #: 04.835.125.02S

Global Unique Device (GUD) Primary Device Identifier Number:

20705034816125

Global Unique Device (GUD) Device Description:

SYNFIX® EVOLUTION FINE TIP SCREW/25MM - STERILE

Category 1: Spine

Category 2: Interbody Fusion Devices

Category 3: Lumbar/T-Lumbar

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Bone-screw internal spinal fixation system, sterile

Global Medical Device Nomenclature (GMDN) Definition:

An assembly of 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. Sterile disposable devices associated with implantation may be included.

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