FDA 510(k) Application Details - K011129

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K011129
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	SIGN, INC. 2950 GEORGE WASHINGTON WAY RICHLAND, WA 99352 US Other 510(k) Applications for this Company
Contact	JEANNE DILLNER 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	04/13/2001
Decision Date	07/11/2001
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