The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Delta Xtend Reverse Shoulder Xlk Cup.
| Device ID | K091751 |
| 510k Number | K091751 |
| Device Name: | DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Dawn Sinclair |
| Correspondent | Dawn Sinclair DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Product Code | KWS |
| Subsequent Product Code | HSD |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-16 |
| Decision Date | 2009-07-14 |
| Summary: | summary |