510(k) K120978

OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR by Merete Medical GmbH — Product Code HSB

K120978 is an FDA 510(k) premarket notification submitted by Merete Medical GmbH for the device "OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR". The FDA issued a decision of Substantially Equivalent on May 2, 2012. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Merete Medical GmbH has at least 10 other 510(k) clearances on record.