510(k) K070773

AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR by Axya Medical, Inc. — Product Code MBI

K070773 is an FDA 510(k) premarket notification submitted by Axya Medical, Inc. for the device "AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR". The FDA issued a decision of Substantially Equivalent on October 11, 2007. 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.