510(k) K982875

MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM by Danek Medical, Inc. — Product Code KWQ

K982875 is an FDA 510(k) premarket notification submitted by Danek Medical, Inc. for the device "MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM". The FDA issued a decision of Substantially Equivalent on January 19, 1999. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Danek Medical, Inc. has at least 10 other 510(k) clearances on record.