The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module.
| Device ID | K191344 |
| 510k Number | K191344 |
| Device Name: | Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module |
| Classification | Plate, Fixation, Bone |
| Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | Rebecca R. Homan R. Homan |
| Correspondent | Rebecca R. Homan 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 | 2019-05-20 |
| Decision Date | 2019-10-03 |