The following data is part of a premarket notification filed by Depuy Ireland Uc with the FDA for C-stem Amt Le Prosthesis.
| Device ID | K220216 |
| 510k Number | K220216 |
| Device Name: | C-Stem AMT LE Prosthesis |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | DePuy Ireland UC Loughbeg, Ringaskiddy Cork, IE |
| Contact | Sarah Matamisa |
| Correspondent | Sarah Matamisa DePuy Orthopaedics, Inc DePuy Ireland UC Loughbeg, Ringaskiddy, Co. Cork, IE |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-26 |
| Decision Date | 2022-07-22 |