The following data is part of a premarket notification filed by Tornier Sas with the FDA for Blueprint Patient Specific Instrumentation.
Device ID | K160555 |
510k Number | K160555 |
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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-29 |
Decision Date | 2016-06-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
93700386998969 | K160555 | 000 |
03700386955648 | K160555 | 000 |