The following data is part of a premarket notification filed by Synthes (usa) Products Llc/depuy Orthopaedics Inc with the FDA for Depuy Synthes Trauma Orthopedic Plates And Screws.
| Device ID | K180310 |
| 510k Number | K180310 |
| Device Name: | DePuy Synthes Trauma Orthopedic Plates And Screws |
| Classification | Plate, Fixation, Bone |
| Applicant | Synthes (USA) Products LLC/DePuy Orthopaedics Inc 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Jeffrey Krawiec |
| Correspondent | Jeffrey Krawiec Synthes (USA) Products LLC/DePuy Orthopaedics Inc 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | HRS |
| Subsequent Product Code | HWC |
| 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 | 2018-02-05 |
| Decision Date | 2018-11-01 |
| Summary: | summary |