The following data is part of a premarket notification filed by Tornier with the FDA for Salto Talaris Total Ankle Prosthesis.
| Device ID | K060544 |
| 510k Number | K060544 |
| Device Name: | SALTO TALARIS TOTAL ANKLE PROSTHESIS |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | TORNIER RUE DOYEN GOSSE St. Ismier, FR 38330 |
| Contact | Mireille Emery |
| Correspondent | Mireille Emery TORNIER RUE DOYEN GOSSE St. Ismier, FR 38330 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-01 |
| Decision Date | 2006-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556832165 | K060544 | 000 |
| 00885556831991 | K060544 | 000 |
| 00885556831984 | K060544 | 000 |
| 00885556831977 | K060544 | 000 |
| 00885556831960 | K060544 | 000 |
| 00885556831953 | K060544 | 000 |
| 00885556831946 | K060544 | 000 |
| 00885556831939 | K060544 | 000 |
| 00885556831922 | K060544 | 000 |
| 00885556831915 | K060544 | 000 |
| 00885556831908 | K060544 | 000 |
| 00885556831892 | K060544 | 000 |
| 00885556831847 | K060544 | 000 |
| 00885556831830 | K060544 | 000 |
| 00885556831823 | K060544 | 000 |
| 00885556832004 | K060544 | 000 |
| 00885556832011 | K060544 | 000 |
| 00885556832158 | K060544 | 000 |
| 00885556832141 | K060544 | 000 |
| 00885556832134 | K060544 | 000 |
| 00885556832127 | K060544 | 000 |
| 00885556832110 | K060544 | 000 |
| 00885556832103 | K060544 | 000 |
| 00885556832097 | K060544 | 000 |
| 00885556832080 | K060544 | 000 |
| 00885556832073 | K060544 | 000 |
| 00885556832066 | K060544 | 000 |
| 00885556832059 | K060544 | 000 |
| 00885556832042 | K060544 | 000 |
| 00885556832035 | K060544 | 000 |
| 00885556832028 | K060544 | 000 |
| 00885556831816 | K060544 | 000 |