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 |