The following data is part of a premarket notification filed by Pixee Medical with the FDA for Knee+.
| Device ID | K220104 |
| 510k Number | K220104 |
| Device Name: | Knee+ |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Pixee Medical 18 Rue Alain Savary Besancon, FR 25000 |
| Contact | Lucie Pecheur |
| Correspondent | Lucie Pecheur Pixee Medical 18 Rue Alain Savary Besancon, FR 25000 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-12 |
| Decision Date | 2022-09-01 |