The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Myspine Webplanner & Mybalance.
| Device ID | K211386 |
| 510k Number | K211386 |
| Device Name: | MySpine WebPlanner & MyBalance |
| Classification | System, Image Processing, Radiological |
| 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 83118 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-05 |
| Decision Date | 2021-07-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630345725905 | K211386 | 000 |
| 07630345725899 | K211386 | 000 |