The following data is part of a premarket notification filed by Mci Medical Concept Innovation Inc. with the FDA for Mci-neuro Fixation System.
| Device ID | K212391 |
| 510k Number | K212391 |
| Device Name: | MCI-Neuro Fixation System |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| Applicant | MCI Medical Concept Innovation Inc. 4592 North Hiatus Road Sunrise, FL 33351 |
| Contact | Carlos Lacerda |
| Correspondent | Graziela Brum Passarini Regulatory Affairs/ PR Servicos Regulatorios Administrativos Ltda ME Rua Alice Alem Saadi, 855/2402 Ribeirao Preto, BR 14096-570 |
| Product Code | GWO |
| Subsequent Product Code | GXR |
| Subsequent Product Code | HBW |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-02 |
| Decision Date | 2022-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811687031955 | K212391 | 000 |
| 00811687031856 | K212391 | 000 |
| 00811687031863 | K212391 | 000 |
| 00811687031870 | K212391 | 000 |
| 00811687031887 | K212391 | 000 |
| 00811687031894 | K212391 | 000 |
| 00811687031900 | K212391 | 000 |
| 00811687031917 | K212391 | 000 |
| 00811687031924 | K212391 | 000 |
| 00811687031931 | K212391 | 000 |
| 00811687031948 | K212391 | 000 |
| 00811687031801 | K212391 | 000 |