FDA 510(k) Application Details - K012161

Device Classification Name	Pin, Fixation, Smooth   More FDA Info for this Device
510(K) Number	K012161
Device Name	Pin, Fixation, Smooth
Applicant	FIXANO SA P.O BOX 12038 LA JOLLA, CA 92039-2038 US Other 510(k) Applications for this Company
Contact	FRANK FERGUSON Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/2001
Decision Date	08/24/2001
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