FDA 510(k) Application Details - K141509

Device Classification Name	More FDA Info for this Device
510(K) Number	K141509
Device Name	ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS
Applicant	MEDOS SARL 325 Paramount Drive Raynham, MA 02767 US Other 510(k) Applications for this Company
Contact	KIRSTEN LEHMULLER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/06/2014
Decision Date	08/22/2014
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