WALNUT CREEK, Calif., Sept. 27, 2017 /PRNewswire/ — Providence Medical Technology, an innovator in cervical spine fusion, today announced FDA 510K clearance for its ALLY™ Posterior Fixation System. The system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for acute and chronic instabilities of the cervical spine (C1 to C7) and is compatible with the company’s flagship DTRAX® Spinal System.
DTRAX Spinal System is a set of sterile packaged, single-use instruments designed to perform posterior cervical fusion and has been used in over 7,000 cases worldwide. Posterior cervical fusion is indicated for patients with symptomatic nerve root involvement and/or mechanical instability. Spinal implants are typically used as an adjunct to posterior cervical fusion cases, and the newly cleared ALLY Posterior Fixation System is the latest addition to the family of spinal fusion implants offered by Providence. Providence also offers CAVUX® Cervical Cages, ALLY Bone Screws, and ALLY Facet Screws as options for spinal instrumentation during cervical fusion procedures.
“We are encouraged by the continued adoption of our posterior cervical fusion technology. Surgeons are increasingly considering posterior cervical fusion with intervertebral cages and supplemental screw fixation when treating patients with cervical spine disorders,” said Providence CEO, Jeff Smith. “The regulatory clearance of ALLY Posterior Fixation System is an important milestone and reflects our commitment to continued innovation and expansion of our differentiated product offering.”
Providence recently announced multiple independent clinical studies supporting the safety, efficacy, and cost-efficiency of its posterior cervical fusion technology. The company will be exhibiting at the annual meeting of the North American Spine Society (NASS) in Orlando, Florida, on October 25-28, booth #1140.
About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative solutions for cervical spinal conditions. The company has pioneered a proprietary approach to posterior cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market. The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, and the ALLY™ line of bone and facet screws. All products are shipped-sterile and single-use to maximize perioperative efficiency and ensure consistent quality and performance. For more information, visit www.providencemt.com
SOURCE Providence Medical Technology