FDA 510(k) Application Details - K183113

Device Classification Name	External Mandibular Fixator And/Or Distractor   More FDA Info for this Device
510(K) Number	K183113
Device Name	External Mandibular Fixator And/Or Distractor
Applicant	Synthes (USA) Products LLC 1301 Goshen Parkway West Chester, PA 19380 US Other 510(k) Applications for this Company
Contact	Rebecca Reiter Other 510(k) Applications for this Contact
Regulation Number	872.4760   More FDA Info for this Regulation Number
Classification Product Code	MQN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2018
Decision Date	03/13/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review