510(k) K131724

PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE by Pioneer Surgical Technology, Inc. — Product Code MQP

K131724 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc. for the device "PIONEER MAXFUSE VERTEBRAL BODY REPLACEMENT DEVICE". The FDA issued a decision of Substantially Equivalent on December 24, 2013. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Pioneer Surgical Technology, Inc. has at least 10 other 510(k) clearances on record.