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 | K183113 |
| 510k Number | K183113 |
| Device Name: | DePuy Synthes Maxillofacial Portfolio - MR Conditional |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | Synthes (USA) Products LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Rebecca Reiter |
| Correspondent | Rebecca Reiter Synthes (USA) Products LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | MQN |
| Subsequent Product Code | DZK |
| Subsequent Product Code | DZL |
| Subsequent Product Code | NEI |
| Subsequent Product Code | OAT |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-09 |
| Decision Date | 2019-03-13 |