The following data is part of a premarket notification filed by Tornier with the FDA for Tornier Elbow Prosthesis.
| Device ID | K050848 |
| 510k Number | K050848 |
| Device Name: | TORNIER ELBOW PROSTHESIS |
| Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
| Applicant | TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier, FR 38334 |
| Contact | Mireille Lemery |
| Correspondent | Mireille Lemery TORNIER 161 RUE LAVOISIER Montbonnot, Saint-ismier, FR 38334 |
| Product Code | JDB |
| CFR Regulation Number | 888.3160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-04 |
| Decision Date | 2005-07-14 |
| Summary: | summary |