The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Calcaneal Fracture Plate System.
| Device ID | K090582 |
| 510k Number | K090582 |
| Device Name: | CALCANEAL FRACTURE PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Contact | Brahim Hadri |
| Correspondent | Brahim Hadri TORNIER, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-04 |
| Decision Date | 2009-07-02 |
| Summary: | summary |