K183232 is an FDA 510(k) clearance for the Double ENDOBUTTON Fixation Device. This device is classified as a Washer, Bolt Nut (Class II - Special Controls, product code HTN).
Submitted by Smith and Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on March 12, 2019, 112 days after receiving the submission on November 20, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K183232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 20, 2018 |
| Decision Date | March 12, 2019 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HTN - Washer, Bolt Nut |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |