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 | K192365 |
| 510k Number | K192365 |
| Device Name: | Shoulder Innovations Total Shoulder System |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| 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 | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-30 |
| Decision Date | 2019-11-29 |
| Summary: | summary |