The following data is part of a premarket notification filed by Arthex, Inc with the FDA for Arthrex Biosync® Bone Wedge.
| Device ID | K151256 |
| 510k Number | K151256 |
| Device Name: | Arthrex BioSync® Bone Wedge |
| Classification | Bone Wedge |
| Applicant | Arthex, Inc 1370 Creekside Boulevard Naples, FL 34108 |
| Contact | Laura Medlin |
| Correspondent | Laura Medlin Arthex, Inc 1370 Creekside Boulevard Naples, FL 34108 |
| Product Code | PLF |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-12 |
| Decision Date | 2015-08-12 |
| Summary: | summary |