This company has registrations in United States, Brazil, Taiwan, Israel — 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 | K231658 | VEOS Spinal Fixation System | 2023-10-10 |
| US | K191726 | mont blanc & mont blanc MIS Spinal Systems | 2019-09-12 |
| US | K162694 | Ayers Rock Cervical interbody fusion system | 2017-01-12 |
| BR | 82507970016 | Instrumentais Poliméricos - Mont Blanc, Mont Blanc MIS e Twin Peaks | Class I |
| BR | 82507970017 | Instrumentais Metálicos - Mont Blanc, Mont Blanc MIS e Twin Peaks | Class I |
| BR | 80454380037 | Kit Instrumental INTERVERTEBRAL | Class I |