The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Delta Xtend Reverse Shoulder High Mobility Cup.
| Device ID | K073676 |
| 510k Number | K073676 |
| Device Name: | DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE Warsaw, IN 46581 -0988 |
| Contact | Rhonda Myer |
| Correspondent | Rhonda Myer 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-28 |
| Decision Date | 2008-01-29 |
| Summary: | summary |