510(k) K060970

AXYALOOP NONABSORBABLE BONE ANCHOR by Axya Medical, Inc. — Product Code JDR

K060970 is an FDA 510(k) premarket notification submitted by Axya Medical, Inc. for the device "AXYALOOP NONABSORBABLE BONE ANCHOR". The FDA issued a decision of Substantially Equivalent on July 5, 2006. The device falls under product code JDR (Staple, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Axya Medical, Inc. has at least 10 other 510(k) clearances on record.