The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Inhancetm Shoulder System – Humeral Stems And Stemless.
| Device ID | K223211 |
| 510k Number | K223211 |
| Device Name: | INHANCETM Shoulder System – Humeral Stems And Stemless |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Depuy Ireland UC Loughbeg Ringaskiddy, IE |
| Contact | Yayoi Fujimaki |
| Correspondent | Russ Parrott Ignite Orthopedics LLC 700 Park Avenue Suite F Winona Lake, IN 46590 |
| Product Code | PHX |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| Subsequent Product Code | MBF |
| Subsequent Product Code | PAO |
| Subsequent Product Code | PKC |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-10-17 |
| Decision Date | 2022-12-02 |