The following data is part of a premarket notification filed by Depuy Synthes with the FDA for Depuy Synthes Trauma Orthopedic Nail Implants.
| Device ID | K182783 |
| 510k Number | K182783 |
| Device Name: | DePuy Synthes Trauma Orthopedic Nail Implants |
| Classification | Plate, Fixation, Bone |
| Applicant | DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Elizabeth Jacobs |
| Correspondent | Elizabeth Jacobs DePuy Synthes 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | HRS |
| Subsequent Product Code | HSB |
| Subsequent Product Code | HTY |
| Subsequent Product Code | JDS |
| Subsequent Product Code | JDW |
| Subsequent Product Code | KTT |
| Subsequent Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-01 |
| Decision Date | 2018-12-26 |
| Summary: | summary |