The following data is part of a premarket notification filed by Onefit Medical with the FDA for Kneeeos.
| Device ID | K161828 |
| 510k Number | K161828 |
| Device Name: | KneeEOS |
| Classification | System, Image Processing, Radiological |
| Applicant | ONEFIT Medical 18 Rue Alain Savary Besancon, FR 25000 |
| Contact | Julien Simon |
| Correspondent | Julien Simon ONEFIT Medical 18 Rue Alain Savary Besancon, FR 25000 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-05 |
| Decision Date | 2016-10-03 |
| Summary: | summary |