The following data is part of a premarket notification filed by Nextremity Solutions, Inc. with the FDA for Duohex Ch Cannulated Hammertoe System.
| Device ID | K200840 |
| 510k Number | K200840 |
| Device Name: | DuoHex CH Cannulated Hammertoe System |
| Classification | Screw, Fixation, Bone |
| Applicant | Nextremity Solutions, Inc. 210 North Buffalo Street Warsaw, IN 46580 |
| Contact | Elise Fox |
| Correspondent | Elise Fox Nextremity Solutions, Inc. 210 North Buffalo Street Warsaw, IN 46580 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-31 |
| Decision Date | 2020-06-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817701026389 | K200840 | 000 |
| 00817701026266 | K200840 | 000 |
| 00817701026273 | K200840 | 000 |
| 00817701026280 | K200840 | 000 |
| 00817701026297 | K200840 | 000 |
| 00817701026303 | K200840 | 000 |
| 00817701026310 | K200840 | 000 |
| 00817701026327 | K200840 | 000 |
| 00817701026334 | K200840 | 000 |
| 00817701026372 | K200840 | 000 |
| 00817701026259 | K200840 | 000 |