The following data is part of a premarket notification filed by Tornier with the FDA for Modification To Tornier Total Elbow Prosthesis.
| Device ID | K031218 |
| 510k Number | K031218 |
| Device Name: | MODIFICATION TO TORNIER TOTAL ELBOW PROSTHESIS |
| Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
| Applicant | TORNIER ZIRST-161, RUE LAVOISIER Montbonnot, FR 38330 |
| Contact | Mireille Lemery |
| Correspondent | Mireille Lemery 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 | 2003-04-17 |
| Decision Date | 2003-05-16 |
| Summary: | summary |