510(k) K112206

CARDIFF ANTERIOR CERVICAL PLATE SYSTEM by Seaspine, Inc. — Product Code KWQ

K112206 is an FDA 510(k) premarket notification submitted by Seaspine, Inc. for the device "CARDIFF ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 25, 2012. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Seaspine, Inc. has at least 10 other 510(k) clearances on record.