The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Fibulock Nail.
| Device ID | K173656 |
| 510k Number | K173656 |
| Device Name: | Arthrex FibuLock Nail |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | Rebecca R. Homan |
| Correspondent | Rebecca R. Homan Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-29 |
| Decision Date | 2018-07-26 |
| Summary: | summary |