The following data is part of a premarket notification filed by Depuy Synthes with the FDA for Depuy Synthes Radial Head Replacement System.
| Device ID | K213563 |
| 510k Number | K213563 |
| Device Name: | DePuy Synthes Radial Head Replacement System |
| Classification | Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Applicant | DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Quinn Mccarthy |
| Correspondent | Quinn Mccarthy DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | KWI |
| CFR Regulation Number | 888.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-09 |
| Decision Date | 2022-03-18 |