FDA 510(k) Application Details - K141508

Device Classification Name	More FDA Info for this Device
510(K) Number	K141508
Device Name	ROMEO 2 PAD POSTERIOR AXIAL DEVICE
Applicant	SPINEART INTERNATIONAL CENTER COINTRIN 20 ROUTE DE PRE-BOIS CP1813 GENEVA 1215 CH Other 510(k) Applications for this Company
Contact	FRANCK PENNESI Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2014
Decision Date	08/21/2014
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