K221283 is an FDA 510(k) clearance for the Hammertoe Truss System (HTS). This device is classified as a Pin, Fixation, Smooth (Class II - Special Controls, product code HTY).
Submitted by 4Web Medical, Inc. (Frisco, US). The FDA issued a Cleared decision on September 6, 2022, 126 days after receiving the submission on May 3, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K221283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2022 |
| Decision Date | September 06, 2022 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HTY - Pin, Fixation, Smooth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |