510(k) K031823

HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 by Implex Corp. — Product Code MQP

K031823 is an FDA 510(k) premarket notification submitted by Implex Corp. for the device "HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1". The FDA issued a decision of Substantially Equivalent on July 11, 2003. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Implex Corp. has at least 10 other 510(k) clearances on record.