FDA 510(k) Application Details - K101859

Device Classification Name	Joint, Knee, External Limb Component   More FDA Info for this Device
510(K) Number	K101859
Device Name	Joint, Knee, External Limb Component
Applicant	RIZZOLI ORTOPEDICA S.P.A. 58A BATES ROAD WATERTOWN, MA 02472 US Other 510(k) Applications for this Company
Contact	DIANE C TIERNAN, MS RAC Other 510(k) Applications for this Contact
Regulation Number	890.3420   More FDA Info for this Regulation Number
Classification Product Code	ISY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2010
Decision Date	10/13/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review