This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 10 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 | K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody | 2026-05-26 |
| US | K260240 | SYMPHONY Navigation Ready Instruments | 2026-03-27 |
| US | K253249 | TriALTIS Spine System | 2025-10-21 |
| BR | 80145901859 | Instrumentais Expedium Osteotomy | Class I |
| BR | 80145901860 | Instrumentais Viper Prime | Class II |
| BR | 80145901478 | AGULHAS CONFIDENCE | Class II |
| SA | ME0000003232SFDAA00001 | HD Coupler C Mount | — |
| SA | ME0000000765SFDAA00024 | EXPEDIUM VERSE® SPINE SYSTEM POWER CORRECTION KEY INSERTER | — |
| CA | 76000 | SWIFT PLUS ANTERIOR CERVICAL PLATE SYSTEM | Class III |
| CA | 87905 | EXPEDIUM SPINE SYSTEM | Class III |
| CA | 98721 | YOGA MICROCATHETERS | Class II |