The following data is part of a premarket notification filed by Arthrosurface Inc. with the FDA for Ovomotion Reverse Shoulder Arthroplasty System.
| Device ID | K203375 |
| 510k Number | K203375 |
| Device Name: | OVOMotion Reverse Shoulder Arthroplasty System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Arthrosurface Inc. 28 Forge Parkway Franklin, ME 02038 |
| Contact | Dawn J. Wilson |
| Correspondent | Dawn J. Wilson Arthrosurface Inc. 28 Forge Parkway Franklin, MA 02038 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-16 |
| Decision Date | 2021-06-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M5288RS410250 | K203375 | 000 |
| M5288RG232000 | K203375 | 000 |
| M5288RS210200 | K203375 | 000 |
| M5288RS210250 | K203375 | 000 |
| M5288RS210300 | K203375 | 000 |
| M5288RS210350 | K203375 | 000 |
| M5288RS210400 | K203375 | 000 |
| M5288RS210450 | K203375 | 000 |
| M5288RS410200 | K203375 | 000 |
| M5288RC150080 | K203375 | 000 |