NuVasive® RELINE® Posterior Fixation System. Catalog #13550000

CataBlog
Dec 9, 2020
1 min read

Updated: May 3, 2024

Vendor/Manufacturer: NuVasive®

Product/Product Line: RELINE® Posterior Fixation System

Vendor/Manufacturer Catalog #: 13550000

Global Unique Device (GUD) Primary Device Identifier Number: 00887517551702

Global Unique Device (GUD) Device Description:

RELINE Lock Screw, 5.5mm Open Tulip

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: KWP, KWQ, MNH, MNI, NKB, OSH

FDA Classification Product Code Device Name:

KWP: Appliance, Fixation, Spinal Interlaminal

KWQ: Appliance, Fixation, Spinal Intervertebral Body

MNH: Orthosis, spondylolisthesis spinal fixation

MNI: Orthosis, Spinal Pedicle Fixation

NKB: Thoracolumbosacral Pedicle Screw System

OSH: Pedicle screw spinal system, adolescent idiopathic scoliosis