The following data is part of a premarket notification filed by Depuy Lnc. with the FDA for Global Shoulder And Delta Cta Systems.
| Device ID | K203230 |
| 510k Number | K203230 |
| Device Name: | Global Shoulder And Delta CTA Systems |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | DePuy Lnc. 700 Orthopaedic Drive Warsaw, IN 46581 -0988 |
| Contact | Megan Bernier |
| Correspondent | Megan Bernier DePuy Lnc. 700 Orthopaedic Drive Warsaw, IN 46581 -0988 |
| Product Code | KWS |
| Subsequent Product Code | HSD |
| Subsequent Product Code | KWT |
| Subsequent Product Code | MBF |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-02 |
| Decision Date | 2021-04-02 |