FDA 510(k) Application Details - K112097

Device Classification Name	System, Facet Screw Spinal Device   More FDA Info for this Device
510(K) Number	K112097
Device Name	System, Facet Screw Spinal Device
Applicant	EXACTECH, INC. 2320 N.W. 66TH CT. GAINESVILLE, FL 32653 US Other 510(k) Applications for this Company
Contact	VLADISLAVA ZAITSEVA 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	07/22/2011
Decision Date	11/21/2011
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