510(k) K183352

Optimus Neuro System by Osteonic Co., Ltd. — Product Code GWO

K183352 is an FDA 510(k) premarket notification submitted by Osteonic Co., Ltd. for the device "Optimus Neuro System". The FDA issued a decision of Substantially Equivalent on January 2, 2019. The device falls under product code GWO (Plate, Cranioplasty, Preformed, Alterable), a Class II device regulated under 21 CFR 882.5320. Osteonic Co., Ltd. has at least 10 other 510(k) clearances on record.