The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Compression Screws.
| Device ID | K170382 |
| 510k Number | K170382 |
| Device Name: | Arthrex Compression Screws |
| Classification | Screw, Fixation, Bone |
| Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -5553 |
| Contact | David L. Rogers |
| Correspondent | David L. Rogers Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-07 |
| Decision Date | 2017-05-11 |
| Summary: | summary |