510(k) K211205

Prase-C Anterior Cervical Plate System by Gbs Commonwealth Co., Ltd. — Product Code KWQ

K211205 is an FDA 510(k) premarket notification submitted by Gbs Commonwealth Co., Ltd. for the device "Prase-C Anterior Cervical Plate System". The FDA issued a decision of Substantially Equivalent on August 12, 2021. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Gbs Commonwealth Co., Ltd. has at least 10 other 510(k) clearances on record.