510(k) K080646

C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM by Biomet Spine — Product Code KWQ

K080646 is an FDA 510(k) premarket notification submitted by Biomet Spine for the device "C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 2, 2008. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Biomet Spine has at least 10 other 510(k) clearances on record.