Xtant Medical Announces FDA 510(k) Clearance of the Xspan™ Laminoplasty Fixation System

by Globe Newswire

BELGRADE, Mont., (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, announced that its wholly owned subsidiary, X-spine Systems, received FDA clearance of the Xspan™ Laminoplasty Fixation System.

The Xspan™ System represents the latest generation of laminoplasty fixation. Spinal laminoplasty is a surgical procedure performed to remove pressure from the spinal cord. Unlike a laminectomy, where the entire lamina is removed, only an opening or window is made on one side of the lamina to alleviate the compression of the spinal cord. The lamina is then restructured by a small plate which allows the spinal canal to increase in size without losing stability or movement in the vertebrae. This procedure can be completed at single or multiple levels.

The Xspan™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3). “We are very pleased to have received clearance for Xspan,” stated Dr. David Kirschman, CSO, EVP, and Director of Xtant Medical. “This system will allow Xtant Medical to further differentiate itself from the competition and will better serve the growing needs of our surgeon partners.”

Xtant Medical estimates the world wide market for laminoplasty at $110M and growing. Xspan will be available to a limited number of key surgeons in the second fiscal quarter of 2016, with a larger general release to follow later in 2016.

See the full article here.

Save time with kBLASTER's unique result management features of sorting, My Favorites, Saved Search and Search History to quickly find your primary predicate, multiple predicates or reference devices to build a successful 510(k) clearance strategy. Save money by enabling self-service extraction of actionable insight from more than 63,000 FDA medical device 510(k) clearance summaries, plus more than 76,000 splash pages for a total of nearly 140,000 records.