The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Arthrosurface Wristmotion Total Wrist Arthroplasty System.
| Device ID | K200718 |
| 510k Number | K200718 |
| Device Name: | Arthrosurface WristMotion Total Wrist Arthroplasty System |
| Classification | Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained |
| 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 | JWJ |
| CFR Regulation Number | 888.3800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-19 |
| Decision Date | 2020-10-15 |