FDA 510(k)

Kentrospine Viktr-MIS® Pedicle screw system

Numéro K : K252139 · 2026-09-27

Date de décision2026-09-27

Code produitNKB

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

Kentrospine Viktr-MIS® Pedicle screw system is the device name listed in this FDA 510(k) record. The listed applicant is Rivarp Medical Pvt., Ltd.. It received FDA 510(k) clearance on 2026-09-27 under 510(k) number K252139. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Kentrospine Viktr-MIS® Pedicle screw system?

Kentrospine Viktr-MIS® Pedicle screw system is a medical device that received FDA 510(k) clearance on 2026-09-27. The listed applicant is Rivarp Medical Pvt., Ltd.. The 510(k) number is K252139.

When did Kentrospine Viktr-MIS® Pedicle screw system receive FDA 510(k) clearance?

Kentrospine Viktr-MIS® Pedicle screw system received FDA 510(k) clearance on 2026-09-27, under 510(k) number K252139.

Who is the listed applicant for Kentrospine Viktr-MIS® Pedicle screw system?

The FDA 510(k) record lists Rivarp Medical Pvt., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kentrospine Viktr-MIS® Pedicle screw system?

The FDA product code for Kentrospine Viktr-MIS® Pedicle screw system is NKB.

Essais cliniques associés

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Source officielle

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