FDA 510(k) Application Details - K150049

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K150049
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	MEDICREA INTERNATIONAL 14 PORTE DU GRAND LYON NEYRON 01700 FR Other 510(k) Applications for this Company
Contact	Audrey Vion Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/12/2015
Decision Date	02/10/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review