510(k) K122497

ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM by Medical Design, LLC — Product Code KWQ

K122497 is an FDA 510(k) premarket notification submitted by Medical Design, LLC for the device "ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 14MM ASFORA ANTERIOR CERVICAL PLATE SYSTEM, ONE LEVEL, 16MM". The FDA issued a decision of Substantially Equivalent on October 15, 2012. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Medical Design, LLC has at least 2 other 510(k) clearances on record.