510(k) K003971

AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR by Axya Medical, Inc. — Product Code MBI

K003971 is an FDA 510(k) premarket notification submitted by Axya Medical, Inc. for the device "AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR". The FDA issued a decision of Substantially Equivalent on March 21, 2001. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Axya Medical, Inc. has at least 10 other 510(k) clearances on record.