The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mecta-c Stand Alone Extension.
| Device ID | K203076 |
| 510k Number | K203076 |
| Device Name: | Mecta-C Stand Alone Extension |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Cervical |
| Applicant | Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874 |
| Contact | Stefano Baj |
| Correspondent | Chris Lussier Medacta USA 3973 Delp Street Memphis, TN 38118 |
| Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-13 |
| Decision Date | 2020-11-06 |