Depuy Synthes VIPER® Cortical Fix Fenestrated Screw System. Catalog #1867-15-000

Updated: May 3

Vendor/Manufacturer: Depuy Synthes

Product/Product Line: VIPER® Cortical Fix Fenestrated Screw System

Vendor/Manufacturer Catalog #: 1867-15-000

Global Unique Device (GUD) Primary Device Identifier Number: 10705034121192

Global Unique Device (GUD) Device Description:

VIPER SYSTEM SINGLE INNER SET SCREW 5.5

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: Lumbar Pedicle Screw Systems

Category 3: Set Screw

FDA Regulation Medical Specialty:

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3070

FDA Regulation Description Classification Name:

Thoracolumbosacral pedicle screw system

FDA Classification Product Code: KWP, KWQ, MNH, MNI, NKB, OSH

FDA Classification Product Code Device Name:

KWP: Appliance, Fixation, Spinal Interlaminal

KWQ: Appliance, Fixation, Spinal Intervertebral Body