510(k) K011912

MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000 by Axya Medical, Inc. — Product Code MBI

K011912 is an FDA 510(k) premarket notification submitted by Axya Medical, Inc. for the device "MODEL 2000 AXYALOOP SELF-TAPPING BONE ANCHOR, MODEL 2000". The FDA issued a decision of Substantially Equivalent on August 31, 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.