The following data is part of a premarket notification filed by Shoulder Innovations, Inc. with the FDA for Shoulder Innovations Total Shoulder System.
| Device ID | K213615 |
| 510k Number | K213615 |
| Device Name: | Shoulder Innovations Total Shoulder System |
| Classification | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained |
| Applicant | Shoulder Innovations, Inc. 13827 Port Sheldon Street Holland, MI 49424 |
| Contact | Don Running |
| Correspondent | Don Running Shoulder Innovations, Inc. 13827 Port Sheldon Street Holland, MI 49424 |
| Product Code | PKC |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-15 |
| Decision Date | 2022-03-11 |