The following data is part of a premarket notification filed by Depuy(ireland) with the FDA for Delta Xtend Revers Shoulder System.
| Device ID | K192448 |
| 510k Number | K192448 |
| Device Name: | Delta Xtend Revers Shoulder System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | DePuy(Ireland) Loughbeg Ringaskiddy Co.cork Munster, IE |
| Contact | Ashley Goncalo |
| Correspondent | Ashley Goncalo DePuy Orthopaedies, Inc. 700 Orthopaedies Dr. Warsaw, IN 46582 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-06 |
| Decision Date | 2019-10-04 |