Kentrospine Viktr-MIS® Pedicle screw system— 510(k) K252139

Name: FDA 510(k) clearance K252139
Creator: U.S. Food and Drug Administration
Published: 2026-09-27

Substantially Equivalent

Rivarp Medical Pvt., Ltd.

FDA 510(k) clearance K252139 for Kentrospine Viktr-MIS® Pedicle screw system, Substantially Equivalent on 2026-09-27. Applicant: Rivarp Medical Pvt., Ltd.. Device class: 2.

Clearance details

Applicant: Rivarp Medical Pvt., Ltd.
Product code: Code NKB
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2025-07-08
Decision date: 2026-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bangalore, IN

Download summary PDF View on FDA.gov ↗

Recent devices under product code NKB

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K261217 — AnyPlus II Spinal Fixation System2026-10-02
K263062 — NOVIX Pedicle Screw System2026-10-01
K262712 — Duet Spinal Fixation System2026-09-30
K263172 — SAS MIS Pelvic Incidence Rods2026-09-30
K262067 — iFuse Granite Onyx Implant System2026-09-23

Adverse events under product code NKB

product code NKB

Death: 27
Injury: 5,033
Malfunction: 4,140
Total: 9,200

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.