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 | K242899 | NOVA Minimally Invasive System | 2024-10-17 |
| US | K191353 | COMET Lumbar Interbody Fusion Cage | 2020-04-14 |
| US | K191494 | Facilis Spinal System | 2019-08-12 |
| BR | 82328860011 | Conjunto de Instrumentos Cirúrgicos para Cage Intervertebral Endoscópi | Class I |
| BR | 82328860012 | Conjunto de Instrumentos Cirúrgicos para Cage Lif Pisces BAUI | Class I |
| BR | 82328860009 | Conjunto de Instrumentos Cirúrgicos para Cage T-Lock BAUI | Class I |