The following data is part of a premarket notification filed by Depuy (ireland) with the FDA for Global Icon Stemless Shoulder System.
| Device ID | K212683 |
| 510k Number | K212683 |
| Device Name: | GLOBAL ICON Stemless Shoulder System |
| Classification | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-constrained |
| Applicant | DePuy (Ireland) Loughbeg Ringaskiddy Co. Cork Munster, IE |
| Contact | Kathy Harris |
| Correspondent | Megan Bernier DePuy Orthopaedics, Inc. 325 Paramount Dr Raynham, MA 02767 |
| Product Code | PKC |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-24 |
| Decision Date | 2022-01-19 |