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 |