510(k) K113303

OSLEOBRIDGE IDSF SPACER CONECTOR by Merete Medical GmbH — Product Code HSB

K113303 is an FDA 510(k) premarket notification submitted by Merete Medical GmbH for the device "OSLEOBRIDGE IDSF SPACER CONECTOR". The FDA issued a decision of Substantially Equivalent on December 9, 2011. 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.