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The Tracker / September 2026 / K252139

510(k) cleared

Kentrospine Viktr-MIS® Pedicle screw system

Rivarp Medical Pvt., Ltd. · Sep 27, 2026 · K252139

FDA cleared the Kentrospine Viktr-MIS® Pedicle screw system from Rivarp Medical Pvt., Ltd. on Sep 27, 2026 under K252139, a traditional 510(k). The device falls under product code NKB, Thoracolumbosacral Pedicle Screw System, regulated at 21 CFR 888.3070 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Jul 8, 2025. The decision came 446 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Rivarp Medical Pvt., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252139?

K252139 is the FDA 510(k) for Kentrospine Viktr-MIS® Pedicle screw system, submitted by Rivarp Medical Pvt., Ltd.. FDA's decision date was Sep 27, 2026, under product code NKB (Thoracolumbosacral Pedicle Screw System).

Who makes the Kentrospine Viktr-MIS® Pedicle screw system?

Rivarp Medical Pvt., Ltd., based in Bangalore, is the applicant of record for K252139.

How long did the K252139 review take?

FDA received the submission on Jul 8, 2025 and issued its decision on Sep 27, 2026, 446 days later.

← All decisions in September 2026