HOFFMAN ESTATES, Ill., Jan. 28 (HSMN NewsFeed) — Life Spine announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to both the DYNA-LINK Spinal System and the PRESIDIO Spinal Plating System. More »
Archive for the ‘CE & FDA’ Category
ST. PAUL, Minn. – (Business Wire) Spineology Inc., developer and manufacturer of minimally invasive spinal surgery devices, announced today that it has received FDA clearance for its minimally invasive surgery (MIS) Capture™ Facet Screw System. More »
NORTH HAVEN, Conn.–(BUSINESS WIRE)–Nov. 11, 2009– Covidien (NYSE: COV), a leading global provider of healthcare products, today announced the launch of DuraSeal™ spine sealant, the first product approved by the U.S. Food and Drug Administration (FDA) for intra-operative sealing of the dural membrane during spine procedures. Nearly 1.5 million spine surgeries are performed in the U.S. every year, with an estimated 10% of these surgeries requiring dural repair and sealing. More »
PARSIPPANY, N.J., Nov. 5 (HSMN NewsFeed) — Regent ACP, Custom Spine’s anterior cervical plate system, has received 510k Clearance from the U.S. Food and Drug Administration (FDA). This product clearance marks the latest addition to Custom Spine’s continually expanding product line. More »








