The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mectafix Cl Fixation Button With Continuous Loop.
| Device ID | K193165 |
| 510k Number | K193165 |
| Device Name: | MectaFix CL Fixation Button With Continuous Loop |
| Classification | Fastener, Fixation, Nondegradable, 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 | MBI |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-15 |
| Decision Date | 2020-02-10 |