The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Plates, Screws, And Staples.
| Device ID | K150456 |
| 510k Number | K150456 |
| Device Name: | Arthrex Plates, Screws, And Staples |
| Classification | Plate, Fixation, Bone |
| Applicant | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | David L Rogers |
| Correspondent | David L Rogers Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | HRS |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-20 |
| Decision Date | 2015-04-29 |
| Summary: | summary |