The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Distal Radius System.
| Device ID | K143749 |
| 510k Number | K143749 |
| Device Name: | Arthrex Distal Radius System |
| Classification | Plate, Fixation, Bone |
| Applicant | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | Laura Medlin |
| Correspondent | Laura Medlin 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 | 2014-12-31 |
| Decision Date | 2015-04-03 |
| Summary: | summary |