The following data is part of a premarket notification filed by Tornier, Sas with the FDA for Blueprint Patient Specific Instrumentation.
| Device ID | K143374 |
| 510k Number | K143374 |
| Device Name: | BLUEPRINT Patient Specific Instrumentation |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | TORNIER, SAS 161 RUE LAVOISIER Montbonnot Saint Martin, FR 38330 |
| Contact | Aymen Azaiez |
| Correspondent | Aymen Azaiez TORNIER, SAS 161 RUE LAVOISIER Montbonnot Saint Martin, FR 38330 |
| Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-25 |
| Decision Date | 2015-04-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 93700386998952 | K143374 | 000 |
| 93700386954897 | K143374 | 000 |
| 93700386954873 | K143374 | 000 |