The following data is part of a premarket notification filed by Medicrea International with the FDA for Medicrea International Anterior Lumbar Plate.
| Device ID | K121323 |
| 510k Number | K121323 |
| Device Name: | MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | MEDICREA INTERNATIONAL 14 PORTE DU GRAND LYON Neyron, FR 01700 |
| Contact | Laure Aviron-violet |
| Correspondent | Laure Aviron-violet MEDICREA INTERNATIONAL 14 PORTE DU GRAND LYON Neyron, FR 01700 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-02 |
| Decision Date | 2012-07-18 |
| Summary: | summary |