FDA 510(k) Application Details - K100043

Device Classification Name	More FDA Info for this Device
510(K) Number	K100043
Device Name	COROENT XLR STANDALONE SYSTEM
Applicant	NUVASIVE, INC. 7475 LUSK BLVD SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	Sheila Bruschi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/08/2010
Decision Date	06/16/2010
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