The following data is part of a premarket notification filed by Depuy (ireland) with the FDA for Depuy Global Unite Shoulder System.
| Device ID | K133834 |
| 510k Number | K133834 |
| Device Name: | DEPUY GLOBAL UNITE SHOULDER SYSTEM |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | DEPUY (IRELAND) LOUGHBEG RINGASKIDDY Co. Cork, IE Ireland |
| Contact | Kellie Myers |
| Correspondent | Kellie Myers DEPUY (IRELAND) LOUGHBEG RINGASKIDDY Co. Cork, IE Ireland |
| Product Code | KWS |
| Subsequent Product Code | HSD |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-17 |
| Decision Date | 2014-04-03 |
| Summary: | summary |