510(k) K994313

MODIFICATION TO BONE ANCHOR AND KIT (BAK) by Axya Medical, Inc. — Product Code GAW

K994313 is an FDA 510(k) premarket notification submitted by Axya Medical, Inc. for the device "MODIFICATION TO BONE ANCHOR AND KIT (BAK)". The FDA issued a decision of Substantially Equivalent on January 13, 2000. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Axya Medical, Inc. has at least 10 other 510(k) clearances on record.