FDA 510(k)

Kentrospine Viktr-MIS® Pedicle screw system

N.º K: K252139 · 2026-09-27

Fecha de decisión2026-09-27

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: NKB)

K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLC

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.