RegulatorySpine

Meditech Spine Receives FDA Clearance for its CURE™ OPEL-L (S) system

ATLANTA, June 1, 2020 /PRNewswire/ — Meditech Spine has received FDA 510(k) clearance to market the CURE™ Opel-L (S) system, a new lumbar plate option which expands upon the previously cleared CURE™ LP Plate System and compliments its Talos®-A (HA) Interbody system. With this approval, Meditech will now offer an Interbody/Plate assembly for the anterior lumbar spine. By adding the Opel™-L (S) plating option to the CURE™ LP product line and pairing it with the Talos® A (HA) interbody system, surgeons now have a nearly limitless opportunity to ideally accommodate individual patient anatomy. The new system has an increased screw angulation and repeatable, more precise A/P alignment with an optional All-in-One drill guide during the placement of the device. By combining the Opel™-L (S) and the Talos®-A (HA) Interbody, surgeons have a lower profile system and streamlined technique improving surgical efficiency while maintaining a robust anterior stabilization.

In addition, Meditech is adding and launching hyper-lordotic sizes to its existing Talos®-A (HA) line of osteoconductive PEEK-OPTIMA® HA Enhanced ALIF implants. With the current CURE™ LP system and the FDA clearance of Opel™-L (S), Meditech offers a comprehensive anterior lumbar system that gives surgeons multiple options when treating complex anterior lumbar spinal procedures. Meditech has targeted the initial launch for this integrated system to take place in the 3rd quarter of 2020. This is the first of three anticipated clearances this year for Meditech Spine.

Meditech continues its relationship with CURE International, the namesake of the CURE ACP, an organization that serves children with physical disabilities in underserved areas of the world. A portion of proceeds from the sale of every plate will help CURE International treat patients in underserved areas who are in need of surgical care.

ABOUT MEDITECH SPINE

Meditech Spine, LLC, is a growing spinal implant company that currently partners with leaders in the industry to design, develop, and distribute implant devices that make a positive difference in the market. Meditech’s pursuit of novel and innovative technologies drives the design and development team. 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 and impression upon those they serve. For more information, visit www.meditechspine.com.

CONTACT

Meditech Spine, LLC
Phone: 678-974-5287
Email: support@meditechspine.com

Caption & Copyright:

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

PEEK-OPTIMA® is a registered trademark of Invibio, Ltd. All rights reserved.

SOURCE Meditech Spine, LLC

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Mike Adams

Mike Adams is a medical device sales leader with extensive clinical experience in spine and biologics and a nationwide distribution network built over the last 10+ years in the industry. He has held various leadership positions in healthcare and device including Distributor Partner, Hospital COO and Spine VP of Sales. He currently leads the commercialization strategy for OrthoSpine Partners and is a Distributor Principal at Novel Medical. Because of his unique career path, Mike has the ability to see the healthcare business from multiple perspectives making him passionate about building strategic partnerships that help reduce overall costs, drive innovation, and cultivate growth for new markets.

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