The following data is part of a premarket notification filed by Onefit Medical with the FDA for Spineeos.
| Device ID | K160407 |
| 510k Number | K160407 |
| Device Name: | SpineEOS |
| 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 | 2016-02-16 |
| Decision Date | 2016-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700757200544 | K160407 | 000 |