510(k) K093127

TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET by Zimmer Trabecular Metal Technology — Product Code MQP

K093127 is an FDA 510(k) premarket notification submitted by Zimmer Trabecular Metal Technology for the device "TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET". The FDA issued a decision of Substantially Equivalent on March 4, 2010. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Zimmer Trabecular Metal Technology has at least 10 other 510(k) clearances on record.