IMBIBE BONE MARROW ASPIRATION NEEDLE

IMBIBE BONE MARROW ASPIRATION NEEDLE is an FDA 510(k)-cleared medical device (K050795) manufactured by Orthovita, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 2, 2005. Regulation: 8.