FDA 510(k) Application Details - K113149

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K113149
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	SYNTHES SPINE 1302 WRIGHTS LN EAST WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	HEATHER GUERIN 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	10/24/2011
Decision Date	02/01/2012
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