The following data is part of a premarket notification filed by Shoulder Innovations, Llc with the FDA for Total Shoulder System.
| Device ID | K111596 |
| 510k Number | K111596 |
| Device Name: | TOTAL SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | SHOULDER INNOVATIONS, LLC 4670 FULTON STREET E Ada, MI 49301 |
| Contact | Andrew Rodenhouse |
| Correspondent | Andrew Rodenhouse SHOULDER INNOVATIONS, LLC 4670 FULTON STREET E Ada, MI 49301 |
| Product Code | KWS |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-08 |
| Decision Date | 2011-07-05 |
| Summary: | summary |