510(k) K051983

MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR by Axya Medical, Inc. — Product Code MAI

K051983 is an FDA 510(k) premarket notification submitted by Axya Medical, Inc. for the device "MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR". The FDA issued a decision of Substantially Equivalent on August 5, 2005. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Axya Medical, Inc. has at least 10 other 510(k) clearances on record.