The following data is part of a premarket notification filed by Tornier, Inc. with the FDA for Ankle Arthrodesis Plate System.
| Device ID | K090139 |
| 510k Number | K090139 |
| Device Name: | ANKLE ARTHRODESIS 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 | 2009-01-21 |
| Decision Date | 2009-10-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832011414 | K090139 | 000 |
| 00846832005383 | K090139 | 000 |
| 00846832005376 | K090139 | 000 |
| 00846832005369 | K090139 | 000 |
| 00846832005352 | K090139 | 000 |
| 00846832005345 | K090139 | 000 |
| 00846832005338 | K090139 | 000 |
| 00846832005321 | K090139 | 000 |
| 00846832005314 | K090139 | 000 |
| 00846832005307 | K090139 | 000 |
| 00846832005000 | K090139 | 000 |
| 00846832004997 | K090139 | 000 |
| 00846832004980 | K090139 | 000 |
| 00846832004973 | K090139 | 000 |
| 00846832004935 | K090139 | 000 |
| 00846832004928 | K090139 | 000 |
| 00846832005390 | K090139 | 000 |
| 00846832005406 | K090139 | 000 |
| 00846832011407 | K090139 | 000 |
| 00846832011391 | K090139 | 000 |
| 00846832011384 | K090139 | 000 |
| 00846832005543 | K090139 | 000 |
| 00846832005536 | K090139 | 000 |
| 00846832005529 | K090139 | 000 |
| 00846832005499 | K090139 | 000 |
| 00846832005482 | K090139 | 000 |
| 00846832005475 | K090139 | 000 |
| 00846832005468 | K090139 | 000 |
| 00846832005451 | K090139 | 000 |
| 00846832005444 | K090139 | 000 |
| 00846832005437 | K090139 | 000 |
| 00846832005420 | K090139 | 000 |
| 00846832005413 | K090139 | 000 |
| 00846832004911 | K090139 | 000 |