FDA 510(k) Application Details - K160698

Device Classification Name	More FDA Info for this Device
510(K) Number	K160698
Device Name	LigaPASS
Applicant	MEDICREA INTERNATIONAL S.A. 14 PORTE DU GRAND LYON NEYRON 01700 FR Other 510(k) Applications for this Company
Contact	DAVID RYAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/14/2016
Decision Date	09/02/2016
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