The following data is part of a premarket notification filed by Tornier with the FDA for Salto Talaris Total Ankle Prosthesis.
| Device ID | K090076 |
| 510k Number | K090076 |
| Device Name: | SALTO TALARIS TOTAL ANKLE PROSTHESIS |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex, FR 38334 |
| Contact | Severine Bonneton |
| Correspondent | Severine Bonneton TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex, FR 38334 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-12 |
| Decision Date | 2009-03-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556832240 | K090076 | 000 |
| 00885556832233 | K090076 | 000 |
| 00885556832226 | K090076 | 000 |
| 00885556832219 | K090076 | 000 |
| 00885556832202 | K090076 | 000 |
| 00885556832196 | K090076 | 000 |
| 00885556832189 | K090076 | 000 |
| 00885556832172 | K090076 | 000 |