510(k) K051000

FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE by Spinal Concepts, Inc. — Product Code MQP

K051000 is an FDA 510(k) premarket notification submitted by Spinal Concepts, Inc. for the device "FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE". The FDA issued a decision of Substantially Equivalent on May 19, 2005. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Spinal Concepts, Inc. has at least 10 other 510(k) clearances on record.