The following data is part of a premarket notification filed by Depuy (ireland) with the FDA for Depuy Global Unite Shoulder System.
| Device ID | K101996 |
| 510k Number | K101996 |
| Device Name: | DEPUY GLOBAL UNITE SHOULDER SYSTEM |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | DEPUY (IRELAND) LOUGHBEG RINGASKIDDY Co. Cork, IE |
| Contact | Rhonda Myer |
| Correspondent | Rhonda Myer DEPUY (IRELAND) LOUGHBEG RINGASKIDDY Co. Cork, IE |
| Product Code | PHX |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| Subsequent Product Code | MBF |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-15 |
| Decision Date | 2010-12-15 |
| Summary: | summary |