The following data is part of a premarket notification filed by Depuy (ireland) with the FDA for Delta Xtend(tm) Reverse Shoulder System.
| Device ID | K192855 |
| 510k Number | K192855 |
| Device Name: | DELTA XTEND(TM) Reverse Shoulder System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | DePuy (Ireland) Loughbeg Ringaskiddy County Cork, IE |
| Contact | Ashley Goncalo |
| Correspondent | Ashley Goncalo Depuy Orthopaedics, Inc 325 Paramount Drive Raynham, MA 02767 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-04 |
| Decision Date | 2020-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295510345 | K192855 | 000 |
| 10603295519058 | K192855 | 000 |
| 10603295519041 | K192855 | 000 |
| 10603295519034 | K192855 | 000 |
| 10603295519027 | K192855 | 000 |
| 10603295519010 | K192855 | 000 |
| 10603295519003 | K192855 | 000 |
| 10603295518990 | K192855 | 000 |
| 10603295518976 | K192855 | 000 |
| 10603295518969 | K192855 | 000 |
| 10603295518792 | K192855 | 000 |
| 10603295519065 | K192855 | 000 |
| 10603295510215 | K192855 | 000 |
| 10603295510338 | K192855 | 000 |
| 10603295510321 | K192855 | 000 |
| 10603295510314 | K192855 | 000 |
| 10603295510307 | K192855 | 000 |
| 10603295510277 | K192855 | 000 |
| 10603295510260 | K192855 | 000 |
| 10603295510253 | K192855 | 000 |
| 10603295510246 | K192855 | 000 |
| 10603295510239 | K192855 | 000 |
| 10603295510222 | K192855 | 000 |
| 10603295518785 | K192855 | 000 |