The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Pro-toe X-flex Hammertoe Fixation System.
| Device ID | K141714 |
| 510k Number | K141714 |
| Device Name: | PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM |
| Classification | Pin, Fixation, Smooth |
| 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 | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-25 |
| Decision Date | 2014-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420166326 | K141714 | 000 |
| 00840420166319 | K141714 | 000 |
| 00840420166302 | K141714 | 000 |
| 00840420166296 | K141714 | 000 |