The following data is part of a premarket notification filed by Synthes (usa) Products Llc/depuy Orthopaedics Inc with the FDA for Depuy Synthes 4.0 Mm And 5.0 Mm Locking Screws – Mr Conditional, Depuy Synthes Wrist Fusion Plate (wfp) – Mr Conditional, Depuy Synthes Large Fragment Dynamic Compression Locking (dcl) System –mr Conditional, Depuy Synthes Small Fragment Dynamic Comp.
| Device ID | K160553 |
| 510k Number | K160553 |
| Device Name: | DePuy Synthes 4.0 Mm And 5.0 Mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Comp |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC 1301 GOSHEN PARKWAY West Chester, PA 19380 |
| Contact | Elizabeth Jacobs |
| Correspondent | Elizabeth Jacobs SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC 1301 GOSHEN PARKWAY West Chester, PA 19380 |
| Product Code | HRS |
| Subsequent Product Code | HSB |
| Subsequent Product Code | HTY |
| Subsequent Product Code | HWC |
| Subsequent Product Code | JDS |
| 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 | 2016-02-29 |
| Decision Date | 2017-06-30 |