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 |