The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Depuy Synthes Maxillofacial Portfolio - Mr Conditional.
| Device ID | K192655 |
| 510k Number | K192655 |
| Device Name: | Depuy Synthes Maxillofacial Portfolio - MR Conditional |
| Classification | Plate, Bone |
| Applicant | Synthes (USA) Products LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Satapa Dhamankar |
| Correspondent | Satapa Dhamankar Synthes (USA) Products LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-25 |
| Decision Date | 2019-12-30 |
| Summary: | summary |