510(k) K182489

4CIS® Pinehurst Anterior Cervical Plate system by Solco Biomedical Co., Ltd. — Product Code KWQ

K182489 is an FDA 510(k) premarket notification submitted by Solco Biomedical Co., Ltd. for the device "4CIS® Pinehurst Anterior Cervical Plate system". The FDA issued a decision of Substantially Equivalent on January 16, 2019. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Solco Biomedical Co., Ltd. has at least 10 other 510(k) clearances on record.