The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mectalock Extension.
| Device ID | K203493 |
| 510k Number | K203493 |
| Device Name: | MectaLock Extension |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| 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 | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-27 |
| Decision Date | 2021-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630345701466 | K203493 | 000 |
| 07630345701459 | K203493 | 000 |
| 07630345701442 | K203493 | 000 |