FDA 510(k) Application Details - K083726

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K083726
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	ORTHOPEDIATRICS, CORP. 210 N. BUFFALO ST. WARSAW, IN 46580 US Other 510(k) Applications for this Company
Contact	GARY BARNETT 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	12/15/2008
Decision Date	03/11/2009
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