510(k) K100070

UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM by Depuy Spine, Inc. — Product Code KWQ

K100070 is an FDA 510(k) premarket notification submitted by Depuy Spine, Inc. for the device "UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 4, 2010. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Depuy Spine, Inc. has at least 10 other 510(k) clearances on record.