The following data is part of a premarket notification filed by Depuy Orthopaedics Inc. with the FDA for Delta Xtend Reverse Shoulder System.
| Device ID | K210167 |
| 510k Number | K210167 |
| Device Name: | DELTA XTEND Reverse Shoulder System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | DePuy Orthopaedics Inc. 700 Orthopaedic Drive Warsaw, IN 46582 |
| Contact | Megan Bernier |
| Correspondent | Megan Bernier DePuy Orthopaedics Inc. 700 Orthopaedic Drive Warsaw, IN 46582 |
| Product Code | PHX |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-01-21 |
| Decision Date | 2021-02-19 |