FDA 510(k) Application Details - K994308

Device Classification Name	System, Facet Screw Spinal Device   More FDA Info for this Device
510(K) Number	K994308
Device Name	System, Facet Screw Spinal Device
Applicant	NUVASIVE, INC. 10065 OLD GROVE RD. SAN DIEGO, CA 92131 US Other 510(k) Applications for this Company
Contact	STEVE REITZLER Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MRW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/1999
Decision Date	04/18/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review