510(k) K051196

TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 by Implex Corp. — Product Code MQP

K051196 is an FDA 510(k) premarket notification submitted by Implex Corp. for the device "TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1". The FDA issued a decision of Substantially Equivalent on June 17, 2005. 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.