The following data is part of a premarket notification filed by Tornier with the FDA for Latitude Elbow Prothesis.
| Device ID | K070787 |
| 510k Number | K070787 |
| Device Name: | LATITUDE ELBOW PROTHESIS |
| Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
| Applicant | TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex, FR 38334 |
| Contact | Mireille Lemery |
| Correspondent | Mireille Lemery TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex, FR 38334 |
| Product Code | JDB |
| CFR Regulation Number | 888.3160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-22 |
| Decision Date | 2007-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832012473 | K070787 | 000 |
| 00846832012466 | K070787 | 000 |
| 00846832012459 | K070787 | 000 |