This company has registrations in United States, Brazil, Canada, Australia — 4 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K173935 | Mediant Anterior Cervical Plating System | 2018-04-16 |
| US | K163326 | SmartEP | 2017-09-29 |
| US | K163056 | Revolution Spinal Fixation System | 2017-02-24 |
| BR | 81771769001 | EQUIPAMENTO DE POTENCIAL EVOCADO | Class II |
| CA | 66272 | SMARTUSB | Class II |