The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Tightrope Ii.
| Device ID | K202581 |
| 510k Number | K202581 |
| Device Name: | Arthrex TightRope II |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | Kelsey N. Roberts |
| Correspondent | Kelsey N. Roberts 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 | 2020-09-08 |
| Decision Date | 2020-11-04 |