FDA 510(k) Application Details - K010322

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K010322
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	ORTHODYNE, INC. 1118 SO. ORANGE AVE. SUITE 204 ORLANDO, FL 32806 US Other 510(k) Applications for this Company
Contact	CARL KNOBLOCH 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	02/02/2001
Decision Date	05/02/2001
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