The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Blunt Tip Screws With Fiber Tape.
| Device ID | K143702 |
| 510k Number | K143702 |
| Device Name: | Arthrex Blunt Tip Screws With Fiber Tape |
| Classification | Pin, Fixation, Smooth |
| Applicant | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | David L Roger |
| Correspondent | David L Roger Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-04-09 |
| Summary: | summary |