The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Delta Shoulder.
| Device ID | K021478 |
| 510k Number | K021478 |
| Device Name: | DELTA SHOULDER |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Janet G Johnson |
| Correspondent | Janet G Johnson DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-08 |
| Decision Date | 2003-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295264095 | K021478 | 000 |
| 10603295264088 | K021478 | 000 |
| 10603295170501 | K021478 | 000 |
| 10603295170495 | K021478 | 000 |
| 10603295170488 | K021478 | 000 |
| 10603295170471 | K021478 | 000 |