510(k) K133518

MAXAN ANTERIOR CERVICAL PLATE SYSTEM by Biomet Spine (Aka Ebi, LLC) — Product Code KWQ

K133518 is an FDA 510(k) premarket notification submitted by Biomet Spine (Aka Ebi, LLC) for the device "MAXAN ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on November 5, 2014. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Biomet Spine (Aka Ebi, LLC) has at least 10 other 510(k) clearances on record.