The following data is part of a premarket notification filed by Tornier Sas with the FDA for Blueprint Patient Specific Instrumentation.
| Device ID | K162800 |
| 510k Number | K162800 |
| 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 | 2016-10-05 |
| Decision Date | 2017-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 93700386998983 | K162800 | 000 |
| 93700386998976 | K162800 | 000 |
| 93700386954903 | K162800 | 000 |
| 93700386954880 | K162800 | 000 |
| 03700386955655 | K162800 | 000 |
| 03700386925726 | K162800 | 000 |