The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Knotless Fibertak Suture Anchor.
| Device ID | K130458 |
| 510k Number | K130458 |
| Device Name: | KNOTLESS FIBERTAK SUTURE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ARTHREX, INC. 1370 Creekside Blvd Naples, FL 34108 |
| Contact | Christina Flores |
| Correspondent | Christina Flores ARTHREX, INC. 1370 Creekside Blvd Naples, FL 34108 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-22 |
| Decision Date | 2013-05-03 |
| Summary: | summary |