K162805 is an FDA 510(k) clearance for the Akros Fibulink Syndesmosis Repair Kit. This device is classified as a Washer, Bolt Nut (Class II - Special Controls, product code HTN).
Submitted by Akros Medical (Durham, US). The FDA issued a Cleared decision on January 10, 2017, 97 days after receiving the submission on October 5, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K162805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 05, 2016 |
| Decision Date | January 10, 2017 |
| Days to Decision | 97 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 |