The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Mesh Plates.
| Device ID | K201677 |
| 510k Number | K201677 |
| Device Name: | Arthrex Mesh Plates |
| Classification | Plate, Fixation, Bone |
| 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 -1945 |
| Product Code | HRS |
| Subsequent Product Code | HTY |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-19 |
| Decision Date | 2020-09-02 |