The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Acl Tightrope®, Pcl Tightrope®, And Tightrope® Ii.
| Device ID | K221128 |
| 510k Number | K221128 |
| Device Name: | Arthrex ACL TightRope®, PCL TightRope®, And TightRope® II |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | Lai Saeteurn |
| Correspondent | Lai Saeteurn Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-18 |
| Decision Date | 2022-10-05 |