The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Knotless Mini Tightropes.
| Device ID | K213644 |
| 510k Number | K213644 |
| Device Name: | Arthrex Knotless Mini TightRopes |
| Classification | Washer, Bolt Nut |
| 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 -5553 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-18 |
| Decision Date | 2021-12-17 |