This company has registrations in United States, Brazil, Canada — 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 | K250444 | NEXUS® Hip Stem | 2025-05-15 |
| US | K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | 2025-02-18 |
| US | K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | 2024-04-18 |
| BR | 81290840018 | INSTRUMENTAL PROCOTYL L | Class I |
| BR | 81290840002 | INSTRUMENTAL SUPERPATH® ESTÉRIL CORTANTE | Class I |
| BR | 81290840003 | INSTRUMENTAL SUPERPATH® ESTÉRIL NÃO CORTANTE | Class I |
| CA | 11596 | DURAMER ADVANTIM TIBIAL INSERT | Class III |
| CA | 11602 | INTERSEAL ACETABULAR SHELL/LINER/CUP | Class III |
| CA | 11848 | DURAMER ADVANTIM PATELLA | Class III |