The following data is part of a premarket notification filed by Arthex, Inc with the FDA for Fibertak Dx.
| Device ID | K172612 |
| 510k Number | K172612 |
| Device Name: | FiberTak DX |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Arthex, Inc 1370 Creekside Boulevard Naples, FL 34108 |
| Contact | Ivette Galmez |
| Correspondent | Ivette Galmez Arthex, Inc 1370 Creekside Boulevard Naples, FL 34108 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-31 |
| Decision Date | 2017-09-28 |
| Summary: | summary |