FDA 510(k) Application Details - K133904

Device Classification Name	More FDA Info for this Device
510(K) Number	K133904
Device Name	CD HORIZON SPINAL SYSTEM GROWTH ROD SET
Applicant	MEDTRONIC SOFAMOR DANEK USA 1800 PYRAMID PLACE MEMPHIS, TN 38132 US Other 510(k) Applications for this Company
Contact	LEE GRANT 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	12/20/2013
Decision Date	02/25/2014
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