FDA 510(k) Application Details - K970748

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component   More FDA Info for this Device
510(K) Number	K970748
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant	SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 BROOKS RD. MEMPHIS, TN 38116 US Other 510(k) Applications for this Company
Contact	JOANNE KUHNE Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	KTT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/1997
Decision Date	05/09/1997
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