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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 K252139
Device Name Kentrospine Viktr-MIS® Pedicle screw system
Applicant
Rivarp Medical Pvt., Ltd.
34, Azeez Sait Industrial Town, 6th Mile, Mysore Rd.,
Nayandahalli
Bangalore,  IN 560039
Applicant Contact Sushma N.R
Correspondent
Rivarp Medical Pvt., Ltd.
34, Azeez Sait Industrial Town, 6th Mile, Mysore Rd.,
Nayandahalli
Bangalore,  IN 560039
Correspondent Contact Sushma N.R
Regulation Number888.3070
Classification Product Code
NKB  
Date Received07/08/2025
Decision Date 09/27/2026
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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