510(k) K022563

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

K022563 is an FDA 510(k) premarket notification submitted by Implex Corp. for the device "HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1". The FDA issued a decision of Substantially Equivalent on August 30, 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.