The following data is part of a premarket notification filed by Tornier Sas with the FDA for 611 Ankle Fusion Nail.
| Device ID | K130051 |
| 510k Number | K130051 |
| Device Name: | 611 ANKLE FUSION NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Tornier SAS 161 RUE LAVOISIER Montbonnot Cedex, FR 38334 |
| Contact | Damien Guillaud |
| Correspondent | Damien Guillaud Tornier SAS 161 RUE LAVOISIER Montbonnot Cedex, FR 38334 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-09 |
| Decision Date | 2013-07-15 |
| Summary: | summary |