FDA 510(k) Application Details - K133052

Device Classification Name	More FDA Info for this Device
510(K) Number	K133052
Device Name	AFFIX(R) NEXT GEN SPINOUS PROCESS PLATE SYSTEM
Applicant	NUVASIVE, INC. 7475 LUSK BLVD SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	OLGA LEWIS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/27/2013
Decision Date	12/20/2013
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