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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K200518
Device Name Pitkar External Fixation System - Rail Mechanism
Applicant
S.H.Pitkar Orthotools Pvt. , Ltd.
Plot # El 32, J Block, Midc Bhosari
Pune,  IN 411026
Applicant Contact Vivek Mangalwedhekar
Correspondent
S.H.Pitkar Orthotools Pvt. , Ltd.
Plot # El 32, J Block, Midc Bhosari
Pune,  IN 411026
Correspondent Contact Vivek Mangalwedhekar
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
JDW  
Date Received03/02/2020
Decision Date 07/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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