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 | K142121 |
| 510k Number | K142121 |
| Device Name: | VALOR HINDFOOT FUSION NAIL SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
| Contact | Jeanine Redden |
| Correspondent | Jeanine Redden WRIGHT MEDICAL TECHNOLOGY, INC. 1023 CHERRY ROAD Memphis, TN 38117 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-04 |
| Decision Date | 2014-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420124494 | K142121 | 000 |
| 00840420144096 | K142121 | 000 |
| 00840420144102 | K142121 | 000 |
| 00840420144119 | K142121 | 000 |
| 00840420144126 | K142121 | 000 |
| 00840420124456 | K142121 | 000 |
| 00840420124463 | K142121 | 000 |
| 00840420124470 | K142121 | 000 |
| 00840420124487 | K142121 | 000 |
| 00840420144089 | K142121 | 000 |