510(k) K143688

ASFORA ANTERIOR CERVICAL PLATE SYSTEM by Medical Designs, LLC — Product Code KWQ

K143688 is an FDA 510(k) premarket notification submitted by Medical Designs, LLC for the device "ASFORA ANTERIOR CERVICAL PLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on July 1, 2015. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Medical Designs, LLC has at least 6 other 510(k) clearances on record.