FDA 510(k)

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments

N.º K: K251154 · 2025-06-12

SolicitanteHt Medical D.B.A. Xenix Medical

Fecha de decisión2025-06-12

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Ht Medical D.B.A. Xenix Medical. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K251154. 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 RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments?

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Ht Medical D.B.A. Xenix Medical. The 510(k) number is K251154.

When did RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments receive FDA 510(k) clearance?

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments received FDA 510(k) clearance on 2025-06-12, under 510(k) number K251154.

Who is the listed applicant for RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments?

The FDA 510(k) record lists Ht Medical D.B.A. Xenix Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments?

The FDA product code for RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments 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

Otros registros que enlistan a Ht Medical D.B.A. Xenix Medical como solicitante

K222988neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical K231829Xenix Medical Sacroiliac Fixation System

Dispositivos relacionados (Código: NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.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.

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.