510(k) K061002

MAXIMA ANTERIOR CERVICAL PLATE SYSTEM by U&I Corp. — Product Code KWQ

K061002 is an FDA 510(k) premarket notification submitted by U&I Corp. for the device "MAXIMA ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 15, 2006. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. U&I Corp. has at least 10 other 510(k) clearances on record.