The following data is part of a premarket notification filed by Arthrex, Inc with the FDA for Arthrex Softstitch.
| Device ID | K222078 |
| 510k Number | K222078 |
| Device Name: | Arthrex SoftStitch |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | Arthrex, Inc 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | Kelsey Roberts |
| Correspondent | Kelsey Roberts 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 | 2022-07-14 |
| Decision Date | 2022-09-14 |