510(k) K122314

QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY by Cayenne Medical, Inc. — Product Code MBI

K122314 is an FDA 510(k) premarket notification submitted by Cayenne Medical, Inc. for the device "QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY". The FDA issued a decision of Substantially Equivalent on October 31, 2012. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Cayenne Medical, Inc. has at least 10 other 510(k) clearances on record.