K162996 is an FDA 510(k) clearance for the INVISIKNOT Ankle Syndesmosis Repair Kit. This device is classified as a Washer, Bolt Nut (Class II - Special Controls, product code HTN).
Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on June 8, 2017, 224 days after receiving the submission on October 27, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K162996 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 2016 |
| Decision Date | June 08, 2017 |
| Days to Decision | 224 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 |