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FDA 510(k)

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments

K-Number: K251154 · 2025-06-12

ApplicantHt Medical D.B.A. Xenix Medical
Decision Date2025-06-12
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments is a medical device manufactured by Ht Medical D.B.A. Xenix Medical. It received FDA 510(k) clearance on 2025-06-12 under approval number K251154. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Ht Medical D.B.A. Xenix Medical. The 510(k) number is K251154.

When was RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments approved by the FDA?

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

What company makes RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments?

RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments is manufactured by Ht Medical D.B.A. Xenix Medical.

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.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED

Related PubMed Literature

PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

Other Devices by Ht Medical D.B.A. Xenix Medical

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

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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