FDA 510(k) Application Details - K190486

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component   More FDA Info for this Device
510(K) Number	K190486
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant	S H Pitkar Orthotools Pvt Ltd. Plot No. EL 32, J Block, MIDC Bhosari Pune 411026 IN Other 510(k) Applications for this Company
Contact	Vivek Mangalwedhekar 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	02/28/2019
Decision Date	10/16/2019
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