510(k) K163366

Shanghai Sanyou CARMEN Cervical Fusion System by Shanghai Sanyou Medical Co, Ltd. — Product Code KWQ

K163366 is an FDA 510(k) premarket notification submitted by Shanghai Sanyou Medical Co, Ltd. for the device "Shanghai Sanyou CARMEN Cervical Fusion System". The FDA issued a decision of Substantially Equivalent on October 5, 2017. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Shanghai Sanyou Medical Co, Ltd. has at least 8 other 510(k) clearances on record.