Medtronic Sofamor Danek ZEVO™ Anterior Cervical Plate System. Catalog #7713517

CataBlog
Jun 21, 2022
1 min read

Vendor/Manufacturer: Medtronic Sofamor Danek

Product/Product Line: ZEVO Anterior Cervical Plate System

Vendor/Manufacturer Catalog #: 7713517

Global Unique Device (GUD) Primary Device Identifier Number: 00643169329294

Global Unique Device (GUD) Device Description:

SCREW 7713517 ZEVO VAR SD 3.5MM X 17MM

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.

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 Submissions: K141632 , K182885

The Medtronic Sofamor Danek ZEVO™ Anterior Cervical Plate System is

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Synthes Spine Anterior Cervical Spine Locking Plate (CSLP) System