Medtronic Sofamor Danek DIVERGENCE™ Anterior Cervical Fusion System. Catalog #G6623513

CataBlog
Jun 21, 2022
1 min read

Vendor/Manufacturer: Medtronic Sofamor Danek

Product/Product Line: DIVERGENCE™Anterior Cervical Fusion System

Vendor/Manufacturer Catalog #: G6623513

Global Unique Device (GUD) Primary Device Identifier Number: 20643169338788

Global Unique Device (GUD) Device Description:

SCREW PK2 G6623513 SA S-D 3.5mm x 13mm

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Spinal bone screw, non-bioabsorbable

Global Medical Device Nomenclature (GMDN) Definition:

A small, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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: OVE

FDA Classification Product Code Device Name:

Intervertebral fusion device with integrated fixation, cervical

FDA Premarket Submissions: K141599

The Medtronic Sofamor Danek DIVERGENCE™Anterior Cervical Fusion System is SUBSTANTIALLY EQUIVALENT to the following product(s):

1. PEEK PREVAIL® Cervical Interbody Device

2. CORNERSTONE® PSR Cervical Fusion System