The following data is part of a premarket notification filed by Tornier with the FDA for Tornier Total Elbow Prosthesis.
Device ID | K011567 |
510k Number | K011567 |
Device Name: | TORNIER TOTAL ELBOW PROSTHESIS |
Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
Applicant | TORNIER ZIRST-161, RUE LAVOISIER Montbonnot, FR 38330 |
Contact | Irene Gosset |
Correspondent | Irene Gosset TORNIER ZIRST-161, RUE LAVOISIER Montbonnot, FR 38330 |
Product Code | JDB |
CFR Regulation Number | 888.3160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-21 |
Decision Date | 2001-06-19 |
Summary: | summary |