The following data is part of a premarket notification filed by Tornier with the FDA for Tornier Cement Restrictor.
| Device ID | K061824 |
| 510k Number | K061824 |
| Device Name: | TORNIER CEMENT RESTRICTOR |
| Classification | Cement Obturator |
| 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 | LZN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-28 |
| Decision Date | 2006-09-14 |
| Summary: | summary |