FDA 510(k) Application Details - K163471

Device Classification Name	More FDA Info for this Device
510(K) Number	K163471
Device Name	Kalitec Direct InSePtionÖ MIS Fixation System
Applicant	KALITEC DIRECT, LLC 618 E. SOUTH STREET SUITE 500 ORLANDO, FL 32801 US Other 510(k) Applications for this Company
Contact	KEITH CANNAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2016
Decision Date	03/16/2017
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