FDA 510(k) Application Details - K991405

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component   More FDA Info for this Device
510(K) Number	K991405
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Applicant	TURNKEY INTERGRATION USA, INC. 962 SOUTH TAMIAMI TRAIL, SUITE 203 SARASOTA, FL 34326 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	KTW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/1999
Decision Date	06/29/1999
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