The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Fiberwire Button Repair Kit, Model Ar-8920ds/ar-8921ds.
| Device ID | K031666 |
| 510k Number | K031666 |
| Device Name: | ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS |
| Classification | Plate, Fixation, Bone |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Ann Waterhouse |
| Correspondent | Ann Waterhouse ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-29 |
| Decision Date | 2003-11-18 |
| Summary: | summary |