510(k) K230301

Athena III Cervical Plate System by Medyssey USA, Inc. — Product Code KWQ

K230301 is an FDA 510(k) premarket notification submitted by Medyssey USA, Inc. for the device "Athena III Cervical Plate System". The FDA issued a decision of Substantially Equivalent on March 7, 2023. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Medyssey USA, Inc. has at least 10 other 510(k) clearances on record.