The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Mectascope System.
| Device ID | K200067 |
| 510k Number | K200067 |
| Device Name: | MectaScope System |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-13 |
| Decision Date | 2020-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630040733540 | K200067 | 000 |
| 07630040733533 | K200067 | 000 |
| 07630040733526 | K200067 | 000 |
| 07630040733519 | K200067 | 000 |
| 07630040733502 | K200067 | 000 |