510(k) K190147

COLOSSEUM Mesh by Globus Medical, Inc. — Product Code MQP

K190147 is an FDA 510(k) premarket notification submitted by Globus Medical, Inc. for the device "COLOSSEUM Mesh". The FDA issued a decision of Substantially Equivalent on May 8, 2019. The device falls under product code MQP (Spinal Vertebral Body Replacement Device), a Class II device regulated under 21 CFR 888.3060. Globus Medical, Inc. has at least 10 other 510(k) clearances on record.