FDA 510(k) Application Details - K964458

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component   More FDA Info for this Device
510(K) Number	K964458
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant	LINK AMERICA, INC. 3700 SOUTH TAMIAMI TRAIL SARASOTA, FL 34239 US Other 510(k) Applications for this Company
Contact	DOUGLAS W STUART 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	11/07/1996
Decision Date	12/09/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review