This company has registrations in United States, Taiwan, Australia — 3 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 | K230872 | Halis Lumbar Cage System, Lydia Anterior Lumbar Fusion System, Dica Direction Changeable Lumbar Cage System, KEYSTONE Cage System | 2023-12-12 |
| US | K230961 | Zeus Spinal System | 2023-10-10 |
| US | K231931 | Adena-Zina Spinal System | 2023-07-28 |