510(k) K133036

APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS by Amendia, Inc. — Product Code MBI

K133036 is an FDA 510(k) premarket notification submitted by Amendia, Inc. for the device "APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS". The FDA issued a decision of Substantially Equivalent on March 6, 2014. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Amendia, Inc. has at least 10 other 510(k) clearances on record.