Meditech Spine Gains FDA Clearance for Cure Opel-C Plating System

By Julie A. Vetalice

Meditech Spine received FDA 510(k) clearance to market the CURE Opel-C Plate spinal implant system, an add-on technology to its CURE anterior cervical plate (ACP) system and Talos-C hydroxyapatite (HA) interbody systems.

CURE Opel-C incorporates the same locking mechanism of CURE ACP, to prevent screws from backing out when anchored in the vertebral body.

This 510(k) provides Meditech Spine two additional CURE ACP plating options with its Talos line of cervical interbodies manufactured from PEEK-OPTIMA™ HA Enhanced polymer.

Since Meditech introduced its CURE ACP system in late 2016, its adoption and usage have seen double-digit growth, according to the company.

Sources: Meditech Spine; ORTHOWORLD, Inc.; image courtesy of Meditech Spine

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory