FDA 510(k) Application Details - K113303

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K113303
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	MERETE MEDICAL GMBH 102 ALT LANKWITZ BERLIN D-12247 DE Other 510(k) Applications for this Company
Contact	EMMANUEL ANAPLIOIS Other 510(k) Applications for this Contact
Regulation Number	888.3020   More FDA Info for this Regulation Number
Classification Product Code	HSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2011
Decision Date	12/09/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review