The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Delta Xtend Reverse Shoulder System.
| Device ID | K203694 |
| 510k Number | K203694 |
| Device Name: | DELTA XTEND Reverse Shoulder System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | DePuy Ireland UC Loughbeg, Ringaskiddy Co. Cork Munster, IE |
| Contact | Jaclyn Cincotta |
| Correspondent | Jaclyn Cincotta DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46582 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-18 |
| Decision Date | 2021-07-22 |