The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Retrobutton, 15mm, 60mm, Retrobutton, Long, 15mm, 60mm.
| Device ID | K062747 |
| 510k Number | K062747 |
| Device Name: | ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM |
| Classification | Plate, Fixation, Bone |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Ann Waterhouse |
| Correspondent | Ann Waterhouse ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | HRS |
| Subsequent Product Code | GAP |
| Subsequent Product Code | GAT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-14 |
| Decision Date | 2006-09-29 |
| Summary: | summary |