FDA 510(k) Application Details - K130147

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K130147
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	SMALL BONE INNOVATIONS, INC. 1380 S. PENNSYLVANIA AVE. MORRISVILLE, PA 19067 US Other 510(k) Applications for this Company
Contact	JOHN MINIER 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	01/22/2013
Decision Date	05/03/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review