The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Arthrosurface Bone Screws.
| Device ID | K172383 |
| 510k Number | K172383 |
| Device Name: | Arthrosurface Bone Screws |
| Classification | Screw, Fixation, Bone |
| Applicant | Arthrosurface, Inc. 28 Forge Parkway Franklin, MA 02038 |
| Contact | Dawn J. Wilson |
| Correspondent | Dawn J. Wilson Arthrosurface, Inc. 28 Forge Parkway Franklin, MA 02038 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-08 |
| Decision Date | 2017-12-22 |
| Summary: | summary |