The following data is part of a premarket notification filed by Shoulder Innovations Inc with the FDA for Humeral Short Stem System.
| Device ID | K173824 |
| 510k Number | K173824 |
| Device Name: | Humeral Short Stem System |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| 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 | MBF |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-18 |
| Decision Date | 2018-10-23 |
| Summary: | summary |