The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex 3.5 Mm Locking Compression Plates.
| Device ID | K222244 |
| 510k Number | K222244 |
| Device Name: | Arthrex 3.5 Mm Locking Compression Plates |
| Classification | Plate, Fixation, Bone |
| Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | Stacy Valdez |
| Correspondent | Stacy Valdez Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-26 |
| Decision Date | 2022-09-30 |