The following data is part of a premarket notification filed by Onefit Medical with the FDA for Onefit Hip Planner.
| Device ID | K142671 |
| 510k Number | K142671 |
| Device Name: | ONEFIT HIP PLANNER |
| 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 | 2014-09-19 |
| Decision Date | 2014-12-05 |
| Summary: | summary |