510(k) K070178

AESCULAP RESORBABLE PIN, MODEL FR735 by Aesculap Implant System, Inc. — Product Code MAI

K070178 is an FDA 510(k) premarket notification submitted by Aesculap Implant System, Inc. for the device "AESCULAP RESORBABLE PIN, MODEL FR735". The FDA issued a decision of Substantially Equivalent on Apr 30, 2007. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Aesculap Implant System, Inc. has at least 10 other 510(k) clearances on record.