K173656 is an FDA 510(k) clearance for the Arthrex FibuLock Nail. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on July 26, 2018, 239 days after receiving the submission on November 29, 2017.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K173656 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2017 |
| Decision Date | July 26, 2018 |
| Days to Decision | 239 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSB — Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |