FDA 510(k) Application Details - K173910

Device Classification Name	Cerclage, Fixation   More FDA Info for this Device
510(K) Number	K173910
Device Name	Cerclage, Fixation
Applicant	Cable Fix Medical LLC 1050 Getwell Road S Hernando, MS 38632 US Other 510(k) Applications for this Company
Contact	Carey Bryant Other 510(k) Applications for this Contact
Regulation Number	888.3010   More FDA Info for this Regulation Number
Classification Product Code	JDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2017
Decision Date	09/14/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review