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 | K062250 |
| 510k Number | K062250 |
| Device Name: | DELTA XTEND REVERSE SHOULDER SYSTEM |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Natalie S Heck |
| Correspondent | Natalie S Heck DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | PHX |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-02 |
| Decision Date | 2007-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295027102 | K062250 | 000 |
| 10603295027256 | K062250 | 000 |
| 10603295027263 | K062250 | 000 |
| 10603295027348 | K062250 | 000 |
| 10603295027355 | K062250 | 000 |
| 10603295027362 | K062250 | 000 |
| 10603295027379 | K062250 | 000 |
| 10603295027386 | K062250 | 000 |
| 10603295027522 | K062250 | 000 |
| 10603295027249 | K062250 | 000 |
| 10603295027232 | K062250 | 000 |
| 10603295027218 | K062250 | 000 |
| 10603295027119 | K062250 | 000 |
| 10603295027133 | K062250 | 000 |
| 10603295027140 | K062250 | 000 |
| 10603295027157 | K062250 | 000 |
| 10603295027164 | K062250 | 000 |
| 10603295027188 | K062250 | 000 |
| 10603295027195 | K062250 | 000 |
| 10603295027201 | K062250 | 000 |
| 10603295027539 | K062250 | 000 |
| 10603295027546 | K062250 | 000 |
| 10603295027805 | K062250 | 000 |
| 10603295027812 | K062250 | 000 |
| 10603295027829 | K062250 | 000 |
| 10603295027836 | K062250 | 000 |
| 10603295027843 | K062250 | 000 |
| 10603295027850 | K062250 | 000 |
| 10603295027867 | K062250 | 000 |
| 10603295027874 | K062250 | 000 |
| 10603295027799 | K062250 | 000 |
| 10603295027782 | K062250 | 000 |
| 10603295027775 | K062250 | 000 |
| 10603295027553 | K062250 | 000 |
| 10603295027690 | K062250 | 000 |
| 10603295027706 | K062250 | 000 |
| 10603295027713 | K062250 | 000 |
| 10603295027720 | K062250 | 000 |
| 10603295027744 | K062250 | 000 |
| 10603295027751 | K062250 | 000 |
| 10603295027768 | K062250 | 000 |
| 10603295027737 | K062250 | 000 |