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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K200937
Device Name ACURA Stabilization System
Applicant
Indius Medical Technologies Pvt. , Ltd.
Unit #12, Electronic Co-Operative Estate, Pune Satara Rd.
Pune Satara Rd.
Pune,  IN 411009
Applicant Contact Aditya Ingalhalikar,
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Nathan Wright
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received04/08/2020
Decision Date 10/26/2020
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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