The following data is part of a premarket notification filed by Synthes Usa Products, Llc with the FDA for Mandible External Fixator - Mr Conditional.
| Device ID | K143285 |
| 510k Number | K143285 |
| Device Name: | Mandible External Fixator - MR Conditional |
| Classification | External Mandibular Fixator And/or Distractor |
| Applicant | Synthes USA Products, LLC 1302 Wrights Lane West Chester, PA 19380 |
| Contact | Susan Lewandowski |
| Correspondent | Susan Lewandowski Synthes USA Products, LLC 1302 Wrights Lane West Chester, PA 19380 |
| Product Code | MQN |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-17 |
| Decision Date | 2015-05-28 |