Meditech Spine Gains Additional FDA Clearance for CURE Lumbar Plate

By Julie A. Vetalice

Meditech Spine received FDA 510(k) clearance for CURE Lumbar Plating (LP) iView and Cure LP QMax, adding sizing options to the company's existing CURE system.

CURE LP received initial FDA clearance in mid-2017 along with lumbar Talos® fusion devices, which are manufactured from PEEK-OPTIMA™ HA Enhanced polymer.

CURE LP-iView is similar to the standard CURE LP anterior plate, but includes a through-hole with rib to nest with the Talos®-A interbody device. QMax is a four-hole direct lateral plate. Anterior and sacral plates and the new iView and Qmax plates will be offered in one tray with streamlined instruments, sterile packaged.

A portion of proceeds from the sale of every plate is donated to CURE International to treat patients in underserved areas.

Source: Meditech Spine LLC

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory