The following data is part of a premarket notification filed by Nextremity Solutions, Inc. with the FDA for Nextra Ch Cannulated Hammertoe System.
| Device ID | K221610 |
| 510k Number | K221610 |
| Device Name: | Nextra CH Cannulated Hammertoe System |
| Classification | Screw, Fixation, Bone |
| Applicant | Nextremity Solutions, Inc. 1195 Polk Drive Warsaw, IN 46582 |
| Contact | Elise Fox |
| Correspondent | Elise Fox Nextremity Solutions, Inc. 1195 Polk Drive Warsaw, IN 46582 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-03 |
| Decision Date | 2022-11-04 |