Meditech Spine Receives FDA Clearance for its Cure™ Opel-C Plating System

ATLANTASept. 18, 2018 /PRNewswire/ — Meditech Spine has received FDA 510(k) clearance to market the Cure™ Opel-C Plate System, an add-on technology to its already cleared CURE™ ACP System and Talos®-C (HA) Interbody Systems. With this approval, Meditech will now offer two additional CURE™ ACP plating options with its Talos® line of cervical interbodies made with the osteoconductive PEEK-OPTIMA® HA Enhanced material. Since Meditech’s introduction of the CURE™ ACP System in late 2016, its adoption and usage have seen double-digit growth. By adding the Opel™-C plating options to the CURE™ ACP product line, surgeons now have two modular snap-on plate styles providing rigid fixation while minimizing adjacent level impact. The Cure™ Opel-C Plate System incorporates the same unique, patented, one-step locking mechanism of the CURE™ ACP System preventing screws from backing out when anchored in the vertebral body. Meditech will be demonstrating the newly approved system at the North American Spine Society (NASS) meeting held in Los Angeles, CA from September 26-28 along with its proprietary Talos® HA Peek Interbody Systems in booth 1757.

Meditech is excited to continue its relationship with CURE International, the namesake of the CURE™ ACP, an organization serving children with physical disabilities in underserved areas of the world. A portion of proceeds from the sale of every plate helps CURE International treat patients in need of surgical care.

For more information visit Meditech Spine.

ABOUT MEDITECH SPINE, LLC

Meditech Spine, LLC, is a growing spinal implant company that partners with leaders in the industry to design, develop, and distribute implant devices that make a positive difference in the market. As Meditech builds on its IP platform, it seeks strategic partnerships and applications to provide surgeons and patients with the best technologies available. Meditech’s belief in the spinal marketplace is to value and honor their partners and all who are touched by their interactions in the development and distribution process so that each experience leaves a positive impact upon those they serve.

CONTACT

Meditech Spine, LLC
(678) 974-5287
support@meditechspine.com

Caption & Copyright:

Talos® and Meditech logos are registered trademarks of Meditech Spine, LLC. All rights reserved.

PEEK-OPTIMA™ is a trademark of Victrex plc or its group companies. All rights reserved.

SOURCE Meditech Spine, LLC

Photo: (PRNewsfoto/Meditech Spine, LLC)

Related Links

http://www.meditechspine.com

By |2018-09-18T16:53:29+00:00September 18th, 2018|Regulatory, Spine, Top Stories|