The following data is part of a premarket notification filed by Medicrea International S.a with the FDA for Medicrea International Anterior Cervical Locking Plate System.
| Device ID | K162194 |
| 510k Number | K162194 |
| Device Name: | MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | MEDICREA INTERNATIONAL S.A 14 PORTE DU GRAND LYON Neyron, FR 01700 |
| Contact | David Ryan |
| Correspondent | David Ryan MEDICREA INTERNATIONAL S.A 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 | 2016-08-05 |
| Decision Date | 2016-12-08 |
| Summary: | summary |