The Aurora Spine ZIP™ MIS Interspinous Fusion System is a bilateral locking plate system which attaches to the posterior non-cervical spine at the spinous processes using Aurora Spine’s one-step, proprietary ZIP-LOCK™ mechanism. The implants have only two components (left & right) to assemble with a central chamber for receiving bone graft. The devices are available […]
FDA
K2M Receives 510(k) Clearance & CE Mark for MESA Hooks Used in Complex Spine Procedures
LEESBURG, Va., Sept. 2, 2014 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO) (the “Company” or “K2M”), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to […]
X-spine Announces FDA Clearance of New Implant System
MIAMISBURG, Ohio, Mar 20, 2013 (BUSINESS WIRE) — X-spine, a global leader in the design and manufacture of devices for the treatment of spinal disease, announces a new USFDA clearance for the Silex(TM) sacroiliac (SI) joint fusion system.The newly-cleared Silex(TM) system allows for fusion and stabilization of the SI joint in eligible patients whom appropriate […]
Alphatec Spine Receives FDA 510(K) Market Clearance for Its Alphatec Solus
CARLSBAD, Mar 12, 2013 (GLOBE NEWSWIRE via COMTEX) — Alphatec Holdings, Inc. , the parent company of Alphatec Spine, Inc., a company with a mission to provide physician-inspired solutions for patients with spinal disorders, announced today that the Company has received clearance from the U.S. Food and Drug Administration (FDA) to market and sell its […]
Vertiflex®, Inc. Announces FDA Clearance of Two Key Additions to Technology Portfolio
SAN CLEMENTE, Calif. —VertiFlex®, Inc., a leading innovator of advanced minimally invasive spinal surgery technologies, today announced FDA 510(k) clearance of two new products to its portfolio: The Totalis™ Direct Decompression System and UniVise™ Spinous Process Fixation System.“These regulatory clearances represent important milestones for VertiFlex® as we rapidly expand our portfolio of innovative interspinous technologies,” […]
Alphatec gains 510(k) clearance for cervical interbody device, fixation system
Alphatec Holdings Inc. was granted 510(k) market clearance from the FDA for the Pegasus and the Illico FS Facet Fixation System, according to a company news release.The Pegasus is an anchored, anterior cervical interbody device which offers single-step deployment of the anchoring blades without impaction. The Illico FS Facet Fixation System is a new minimally […]
FDA gives Zimmer recall its most serious score
WASHINGTON — The Food and Drug Administration said Friday that more than 300 spinal surgical instruments recalled last week by Zimmer Holdings Inc. could potentially cause serious injury or death. Zimmer announced Dec. 20 it was recalling 315 Peek Ardis Inserters after reports that the devices could cause surgical delays and injury when used with […]
Precision Spine™ Announces FDA 510(k) Clearance for its Minimally Invasive Access System
PARSIPPANY, N.J.–(BUSINESS WIRE)–Precision Spine announced today that it received 510(k) clearance from the FDA on November 20, 2012 for its Mini-Max Minimally Invasive Access System.“The development of the Mini-Max Minimally Invasive Access System represents what we believe to be the next evolutionary step in the ongoing advancement of MIS spine procedures. I believe that the […]
Integra LifeSciences Receives FDA Clearance for Expanded Indication for Spinal Device
PLAINSBORO, N.J., Oct. 9, 2012 (GLOBE NEWSWIRE) — Integra® LifeSciences Holdings Corporation (Nasdaq:IART) today announced that the Food and Drug Administration (FDA) has approved an expanded indication for use of the Integra® Vu aPOD™ Prime Intervertebral Body Fusion Device (IBD) in anterior lumbar interbody fusion (ALIF) procedures. The new stand-alone indication includes four points of […]