The following data is part of a premarket notification filed by Depuy Synthes with the FDA for Depuy Synthes Plates And Screws Portfolio.
| Device ID | K190750 |
| 510k Number | K190750 |
| Device Name: | DePuy Synthes Plates And Screws Portfolio |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| Subsequent Product Code | JDO |
| Subsequent Product Code | JDP |
| Subsequent Product Code | KTT |
| Subsequent Product Code | KTW |
| Subsequent Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-25 |
| Decision Date | 2019-06-21 |