510(k) K082037

SEEPLATE CERVICAL PLATE SYSTEM by Amedica Corp. — Product Code KWQ

K082037 is an FDA 510(k) premarket notification submitted by Amedica Corp. for the device "SEEPLATE CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on September 26, 2008. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Amedica Corp. has at least 10 other 510(k) clearances on record.