The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Softstitch.
| Device ID | K190707 |
| 510k Number | K190707 |
| Device Name: | Arthrex SoftStitch |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | David L Rogers |
| Correspondent | David L Rogers Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-19 |
| Decision Date | 2020-10-02 |