FDA 510(k)

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments

Numéro K : K251154 · 2025-06-12

DemandeurHt Medical D.B.A. Xenix Medical

Date de décision2025-06-12

Code produitNKB

Comité consultatifOR

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Ht Medical D.B.A. Xenix Medical en tant que demandeur

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

Dispositifs connexes (Code : 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.

Source officielle

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