The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Tenodesis Button.
| Device ID | K190288 |
| 510k Number | K190288 |
| Device Name: | Arthrex Tenodesis Button |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | Ivette Galmez |
| Correspondent | Ivette Galmez 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 | 2019-02-11 |
| Decision Date | 2019-09-13 |
| Summary: | summary |