CataBlog
- May 6
- 1 min read

DePuy Synthes SYMPHONY™ OccipitoCervico-Thoracic (OCT) System. Catalog #1020-64-075

Vendor/Manufacturer: DePuy Synthes

Product/Product Line: SYMPHONY™ OccipitoCervico-Thoracic (OCT) System

Vendor/Manufacturer Catalog #: 1020-64-075

Global Unique Device (GUD) Primary Device Identifier Number:

10705034511887

Global Unique Device (GUD) Device Description:

SYMPHONY OCT SYSTEM PRE-CUT PRE-LORDOSED ROD TITANIUM ALLOY diameter 4.0 X 75mm

Category 1: Spine

Category 2: Posterior Cervical Systems

Category 3: Rod

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: 888.3075

FDA Regulation Description Classification Name:

Posterior cervical screw system

FDA Classification Product Code(s): KWP, NKG

FDA Classification Product Code Device Name(s):

KWP: Appliance, Fixation, Spinal Interlaminal

NKG: Orthosis, cervical pedicle screw spinal fixation

FDA Premarket Submissions: K190895 , K181949

The DePuy Synthes SYMPHONY™ OccipitoCervico-Thoracic (OCT) System is SUBSTANTIALLY EQUIVALENT to the following product(s):

1. SYNAPSE OCT System by DePuy Synthes