The following data is part of a premarket notification filed by Synthes (usa) Products Llc with the FDA for Depuy Synthes Craniomaxillofacial Neuro Devices - Mr Conditional.
| Device ID | K192702 |
| 510k Number | K192702 |
| Device Name: | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional |
| Classification | Plate, Cranioplasty, Preformed, Non-alterable |
| Applicant | Synthes (USA) Products LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Jeffrey Krawiec |
| Correspondent | Jeffrey Krawiec Synthes (USA) Products LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | GXN |
| Subsequent Product Code | DZL |
| Subsequent Product Code | GWO |
| Subsequent Product Code | GXR |
| Subsequent Product Code | JEY |
| Subsequent Product Code | MQN |
| CFR Regulation Number | 882.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-27 |
| Decision Date | 2020-09-18 |