The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Fibertak Suture Anchor.
| Device ID | K181769 |
| 510k Number | K181769 |
| Device Name: | Arthrex FiberTak Suture Anchor |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | David L. Rogers |
| Correspondent | David L. Rogers Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-03 |
| Decision Date | 2018-09-21 |
| Summary: | summary |