FDA 510(k) Application Details - K123745

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K123745
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	BIOMECANICA INDUSTRIA E COMERICO DE PRODUCTOS ORTO 18851 NE 29TH AVE 720 AVENTURA, FL 33180 US Other 510(k) Applications for this Company
Contact	TARA CONRAD 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	12/06/2012
Decision Date	03/25/2013
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