"Meditech is one of the few manufacturers that has this indication and the only company with FDA clearance of Invibio’s PEEK-OPTIMA®HA Enhanced utilizing autograft or allograft with the Talos®-C (HA) cervical interbody devices."
Atlanta, GA (PRWEB) October 15, 2015
Meditech Spine, a manufacturer of spinal implants, has received clearance from the FDA for its Talos® interbody devices for use with allograft comprised of cancellous or corticocancellous bone graft.
This means that now, all of Meditech’s interbody cervical devices and lumbar devices are indicated for use with autograft or allograft. These devices include the Talos®-P, Talos®-T, Talos®-A, Talos®-L, and both the Talos®-C and Talos®-C (HA) interbody implants.
Meditech is one of the few manufacturers that has this indication and the only company with FDA clearance of Invibio’s PEEK-OPTIMA®HA Enhanced utilizing autograft or allograft with the Talos®-C (HA) cervical interbody devices.
“We are pleased to have received this news from the FDA. Surgeons can now have confidence and peace of mind to use what’s best for their patients,” Meditech Spine Vice President of Sales Bob Wolownik said.
“This continues to build on our platform of products, especially our recently cleared Talos®-C (HA) devices that are being adopted by surgeons,” Wolownik said. “By combining HA with the world’s leading spinal implant material PEEK-OPTIMA Natural and giving surgeons the option of autograft or allograft, we have delivered a game-changing implant.”
“The Talos®-C (HA) addresses many of the concerns that surgeons have with existing implant materials. We are thrilled to be one of the first companies to offer this novel product to the market, arming surgeons with new technology that will result in improved patient outcomes,” Wolownik said.
For further information, visit Meditech Spine online at http://www.meditechspine.com.
Caption & Copyright:
Talos® is a registered trademark of Meditech Spine, LLC. All rights reserved.
PEEK-OPTIMA® is a registered trademark of Invibio, Ltd. All rights reserved.
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. After obtaining its initial 510(k) in 2009, Meditech has obtained three additional clearances with the FDA and has successfully launched five products. 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, contact:
Bob Wolownik, VP of Sales
Meditech Spine, LLC
1447 Peachtree Street, Suite 440
Atlanta, GA 30309
Phone: (678) 974-5287
SOURCE: Meditech Spine, LLC