The following data is part of a premarket notification filed by Tornier Sas with the FDA for Salto Talaris Total Ankle Prosthesis, Rhs.
| Device ID | K130533 |
| 510k Number | K130533 |
| Device Name: | SALTO TALARIS TOTAL ANKLE PROSTHESIS, RHS |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | Tornier SAS 161 RUE LAVOISIER Montbonnot Saint Martin, FR 38330 |
| Contact | Severine Bonneton |
| Correspondent | Severine Bonneton Tornier SAS 161 RUE LAVOISIER Montbonnot Saint Martin, FR 38330 |
| Product Code | HSN |
| Subsequent Product Code | JDB |
| Subsequent Product Code | KWI |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-01 |
| Decision Date | 2013-05-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780365143 | K130533 | 000 |
| 00885556831878 | K130533 | 000 |
| 00885556831861 | K130533 | 000 |
| 00885556831854 | K130533 | 000 |
| 00885556831809 | K130533 | 000 |
| 00885556831793 | K130533 | 000 |
| 00885556831786 | K130533 | 000 |
| 00885556831779 | K130533 | 000 |
| 00885556831762 | K130533 | 000 |
| 00885556831755 | K130533 | 000 |
| 00885556831748 | K130533 | 000 |
| 00885556831885 | K130533 | 000 |
| 10381780365037 | K130533 | 000 |
| 10381780365136 | K130533 | 000 |
| 10381780365129 | K130533 | 000 |
| 10381780365112 | K130533 | 000 |
| 10381780365105 | K130533 | 000 |
| 10381780365099 | K130533 | 000 |
| 10381780365082 | K130533 | 000 |
| 10381780365075 | K130533 | 000 |
| 10381780365068 | K130533 | 000 |
| 10381780365051 | K130533 | 000 |
| 10381780365044 | K130533 | 000 |
| 00885556831731 | K130533 | 000 |