510(k) K021967

HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2 by Implex Corp. — Product Code MQP

K021967 is an FDA 510(k) premarket notification submitted by Implex Corp. for the device "HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2". The FDA issued a decision of Substantially Equivalent on July 17, 2002. 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.