The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Arthrosurface Bone Screws.
| Device ID | K161539 |
| 510k Number | K161539 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-03 |
| Decision Date | 2016-06-30 |
| Summary: | summary |