The following data is part of a premarket notification filed by Tornier with the FDA for Tornier Total Elbow Prosthesis.
| Device ID | K000003 |
| 510k Number | K000003 |
| Device Name: | TORNIER TOTAL ELBOW PROSTHESIS |
| Classification | Prosthesis, Elbow, Constrained, Cemented |
| Applicant | TORNIER 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf TORNIER 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | JDC |
| CFR Regulation Number | 888.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-03 |
| Decision Date | 2000-10-02 |