FDA 510(k) Application Details - K123138

Device Classification Name	More FDA Info for this Device
510(K) Number	K123138
Device Name	PASS LP SPINAL SYSTEM
Applicant	MEDICREA INTERNATIONAL 14 PORTE DU GRAND LYON NEYRON 01700 FR Other 510(k) Applications for this Company
Contact	LAURE AVIRON-VIOLET Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OSH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/05/2012
Decision Date	02/05/2013
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review