The following data is part of a premarket notification filed by Medicrea International S. A. with the FDA for C-curve Interbody Fusion Device.
| Device ID | K210470 |
| 510k Number | K210470 |
| Device Name: | C-CURVE Interbody Fusion Device |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | Medicrea International S. A. 5389 Route De Strasbourg - Vancia Rillieux-la-pape, FR 69140 |
| Contact | Karine Trogneux |
| Correspondent | Karine Trogneux Medicrea International S. A. 5389 Route De Strasbourg - Vancia Rillieux-la-pape, FR 69140 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-17 |
| Decision Date | 2021-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03613720283621 | K210470 | 000 |
| 03613720275107 | K210470 | 000 |
| 03613720275091 | K210470 | 000 |
| 03613720275084 | K210470 | 000 |
| 03613720274445 | K210470 | 000 |
| 03613720274346 | K210470 | 000 |
| 03613720274322 | K210470 | 000 |
| 03613720274315 | K210470 | 000 |
| 03613720274209 | K210470 | 000 |
| 03613720274193 | K210470 | 000 |
| 03613720274179 | K210470 | 000 |
| 03613720275114 | K210470 | 000 |
| 03613720275138 | K210470 | 000 |
| 03613720275145 | K210470 | 000 |
| 03613720283225 | K210470 | 000 |
| 03613720282686 | K210470 | 000 |
| 03613720281597 | K210470 | 000 |
| 03613720275695 | K210470 | 000 |
| 03613720275688 | K210470 | 000 |
| 03613720275671 | K210470 | 000 |
| 03613720275664 | K210470 | 000 |
| 03613720275657 | K210470 | 000 |
| 03613720275244 | K210470 | 000 |
| 03613720275152 | K210470 | 000 |
| 03613720274162 | K210470 | 000 |