The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Valor Ankle Fusion Nail System.
| Device ID | K090857 |
| 510k Number | K090857 |
| Device Name: | VALOR ANKLE FUSION NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Contact | Kellen Hills |
| Correspondent | Kellen Hills WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-30 |
| Decision Date | 2009-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420124364 | K090857 | 000 |
| 00840420115874 | K090857 | 000 |
| 00840420115867 | K090857 | 000 |
| 00840420115850 | K090857 | 000 |
| 00840420115843 | K090857 | 000 |
| 00840420115836 | K090857 | 000 |
| 00840420115829 | K090857 | 000 |
| 00840420115812 | K090857 | 000 |
| 00840420115805 | K090857 | 000 |
| 00840420115881 | K090857 | 000 |
| 00840420115898 | K090857 | 000 |
| 00840420124357 | K090857 | 000 |
| 00840420124340 | K090857 | 000 |
| 00840420115959 | K090857 | 000 |
| 00840420115942 | K090857 | 000 |
| 00840420115935 | K090857 | 000 |
| 00840420115928 | K090857 | 000 |
| 00840420115911 | K090857 | 000 |
| 00840420115904 | K090857 | 000 |
| 00840420115799 | K090857 | 000 |