The following data is part of a premarket notification filed by Fixano Sa with the FDA for Radiofix.
| Device ID | K012078 |
| 510k Number | K012078 |
| Device Name: | RADIOFIX |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | FIXANO SA P.O BOX 12038 La Jolla, CA 92039 -2038 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson FIXANO SA P.O BOX 12038 La Jolla, CA 92039 -2038 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-02 |
| Decision Date | 2001-09-27 |
| Summary: | summary |