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FDA 510(k)

RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System

K-Number: K232348 · 2023-10-27

ApplicantMiRus, LLC
Decision Date2023-10-27
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is MiRus, LLC. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K232348. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System?

RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is MiRus, LLC. The 510(k) number is K232348.

When did RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System receive FDA 510(k) clearance?

RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System received FDA 510(k) clearance on 2023-10-27, under 510(k) number K232348.

Who is the listed applicant for RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System?

The FDA 510(k) record lists MiRus, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System?

The FDA product code for RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System is OVE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITINGNCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT05883436Investigation of DEXA-C Anterior Cervical Interbody SystemACTIVE_NOT_RECRUITINGNCT04388332ACDF Using Structural Allograft vs. Tritanium CRECRUITINGNCT05740176The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion SurgeryACTIVE_NOT_RECRUITINGNCT06462729LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)RECRUITING

Other records listing MiRus, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsK252733ATLAS™ Expandable Osteotomy Wedge SystemK242516EUROPA™ Posterior Cervical Fusion SystemK241175MiRus MoRe Lumbar Plating SystemK232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemK232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation

View all 24 devices →

Related Devices (Code: OVE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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