The following data is part of a premarket notification filed by Gm Dos Reis Industria E Comercio Ltda with the FDA for Expert - Joint Fixation System.
| Device ID | K200332 |
| 510k Number | K200332 |
| Device Name: | EXPERT - Joint Fixation System |
| Classification | Washer, Bolt Nut |
| Applicant | GM Dos Reis Industria E Comercio Ltda Avenida Pierre Simon De La Place 600 Campinas, BR 13069320 |
| Contact | Paula Oliveira |
| Correspondent | Graziela Brum PR Servicos Regulatorios Administrativos Ltda Rua Alice Alem Saadi, 855/2402 Ribeirao Preto, BR 14096-570 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-10 |
| Decision Date | 2020-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07899258642536 | K200332 | 000 |
| 07899258638850 | K200332 | 000 |
| 07899258638843 | K200332 | 000 |