510(k) K051971

OPTIMA SPINAL SYSTEM by U&I Corp. — Product Code KWQ

K051971 is an FDA 510(k) premarket notification submitted by U&I Corp. for the device "OPTIMA SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on August 4, 2005. 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.