The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for Global Unite Platform Shoulder System.
| Device ID | K170748 |
| 510k Number | K170748 |
| Device Name: | GLOBAL UNITE Platform Shoulder System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | DePuy Ireland UC Loughbeg Ringaskiddy, IE |
| Contact | Carol Sandberg Ming |
| Correspondent | Kellie Myers DePuy Orthopaedics, Inc. 700 Orthopaedic Dr. Warsaw, IN 46582 |
| 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 | 2017-03-10 |
| Decision Date | 2018-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10603295116592 | K170748 | 000 |
| 10603295116103 | K170748 | 000 |
| 10603295116097 | K170748 | 000 |
| 10603295116080 | K170748 | 000 |
| 10603295116066 | K170748 | 000 |
| 10603295116059 | K170748 | 000 |
| 10603295116042 | K170748 | 000 |
| 10603295116035 | K170748 | 000 |
| 10603295116028 | K170748 | 000 |
| 10603295116110 | K170748 | 000 |
| 10603295116127 | K170748 | 000 |
| 10603295116134 | K170748 | 000 |
| 10603295116523 | K170748 | 000 |
| 10603295116448 | K170748 | 000 |
| 10603295116349 | K170748 | 000 |
| 10603295116189 | K170748 | 000 |
| 10603295116172 | K170748 | 000 |
| 10603295116165 | K170748 | 000 |
| 10603295116158 | K170748 | 000 |
| 10603295116141 | K170748 | 000 |
| 10603295164661 | K170748 | 000 |