NuVasive® RELINE® Posterior Fixation System. Catalog #16171111

CataBlog
Dec 8, 2020
1 min read

Updated: May 1, 2024

Vendor/Manufacturer: NuVasive®

Product/Product Line: RELINE® Posterior Fixation System

Vendor/Manufacturer Catalog #: 16171111

Global Unique Device (GUD) Primary Device Identifier Number:

00887517587497

Global Unique Device (GUD) Device Description:

RELINE Tulip, MOD

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: 888.3070

FDA Regulation Description Classification Name:

Thoracolumbosacral pedicle screw system

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

FDA Classification Product Code Device Name:

NKB: Thoracolumbosacral Pedicle Screw System

OSH: Pedicle screw spinal system, adolescent idiopathic scoliosis

KWQ: Appliance, Fixation, Spinal Intervertebral Body

MNI: Orthosis, Spinal Pedicle Fixation

KWP: Appliance, Fixation, Spinal Interlaminal