510(k) K040397

MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM by Encore Medical L.P. — Product Code KWQ

K040397 is an FDA 510(k) premarket notification submitted by Encore Medical L.P. for the device "MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on May 6, 2004. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Encore Medical L.P. has 81 other 510(k) clearances on record.