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 |