The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Valor Hindfoot Fusion Nail System.
| Device ID | K142602 |
| 510k Number | K142602 |
| Device Name: | VALOR Hindfoot Fusion Nail System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
| Contact | Val Myles |
| Correspondent | Val Myles WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-15 |
| Decision Date | 2014-10-22 |
| Summary: | summary |