FDA 510(k) Application Details - K101934

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K101934
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	MEDSHAPE SOLUTIONS 1575 NORTHSIDE DR. SUITE 440 ATLANTA, GA 30318 US Other 510(k) Applications for this Company
Contact	DON GRIFFIN 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	07/12/2010
Decision Date	08/03/2011
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