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 Screws.
| Device ID | K192745 |
| 510k Number | K192745 |
| Device Name: | DePuy Synthes Trauma Screws |
| Classification | Screw, Fixation, Bone |
| Applicant | Synthes (USA) Products LLC / DePuy Orthopaedics Inc 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Keith Knapp |
| Correspondent | Keith Knapp Synthes (USA) Products LLC / DePuy Orthopaedics Inc 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | HWC |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HTN |
| Subsequent Product Code | HTY |
| Subsequent Product Code | JDS |
| Subsequent Product Code | JDW |
| Subsequent Product Code | KTT |
| Subsequent Product Code | NDG |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2019-11-26 |
| Summary: | summary |