FDA 510(k) Application Details - K153348

Device Classification Name	More FDA Info for this Device
510(K) Number	K153348
Device Name	JAZZ LOCK
Applicant	Implanet, S.A. Technopole Bordeaux Montesquieu Allee Francois Magendie Martillac 33650 FR Other 510(k) Applications for this Company
Contact	Regis Le Couedic 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	11/20/2015
Decision Date	03/31/2016
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