The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Delta Humeral Cups.
| Device ID | K050315 |
| 510k Number | K050315 |
| Device Name: | DELTA HUMERAL CUPS |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Tiffani D Rogers |
| Correspondent | Tiffani D Rogers DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-09 |
| Decision Date | 2005-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295170525 | K050315 | 000 |
| 10603295170518 | K050315 | 000 |
| 10603295170464 | K050315 | 000 |
| 10603295170457 | K050315 | 000 |