The following data is part of a premarket notification filed by Arthrosurface, Inc. with the FDA for Ovomotion Shoulder Arthroplasty System.
| Device ID | K173964 |
| 510k Number | K173964 |
| Device Name: | OVOMotion Shoulder Arthroplasty System |
| Classification | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| 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 | HSD |
| CFR Regulation Number | 888.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-29 |
| Decision Date | 2018-04-18 |
| Summary: | summary |