This company has registrations in United States, Brazil — 2 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 | K191289 | Bone Screw Line Addition | 2019-07-29 |
| US | K190543 | Cannulated Hemi Implant | 2019-05-31 |
| US | K163487 | Ultima HA Coated Half Pins and Wire | 2017-02-13 |
| BR | 80781610001 | Fixador Circular Hexapode Dynex Vilex | Class I |
| BR | 80047300729 | KIT INSTRUMENTAL ORTHEX | Class I |
| BR | 80047300735 | CAIXAS de ESTERILIZAÇÃO ORTHEX | Class I |