Depuy Synthes SKYLINE Anterior Cervical Plate System. Catalog #1868-01-012

CataBlog
Nov 23, 2020
2 min read

Updated: Apr 29, 2024

Vendor/Manufacturer: Depuy Synthes

Product/Product Line: SKYLINE Anterior Cervical Plate System

Vendor/Manufacturer Catalog #: 1868-01-012

Global Unique Device (GUD) Primary Device Identifier Number: 10705034133546

Global Unique Device (GUD) Device Description:

SKYLINE ANTERIOR CERVICAL PLATE SYSTEM ONE LEVEL PLATE 12mm

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: Cervical Plate & Screw Systems

Category 3: Plate

Category 4: One Level

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: K052552 , K171439