510(k) K061576

MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM by Quantum Orthopedics, Inc. — Product Code MQP

K061576 is an FDA 510(k) premarket notification submitted by Quantum Orthopedics, Inc. for the device "MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on July 3, 2006. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Quantum Orthopedics, Inc. has at least 5 other 510(k) clearances on record.