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FDA 510(k)

RIGEL™ 3DR Anterior Cervical Corpectomy System

K-Number: K232481 · 2023-10-13

ApplicantMiRus, LLC
Decision Date2023-10-13
Product CodePLR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RIGEL™ 3DR Anterior Cervical Corpectomy 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 2023-10-13 under 510(k) number K232481. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIGEL™ 3DR Anterior Cervical Corpectomy System?

RIGEL™ 3DR Anterior Cervical Corpectomy System is a medical device that received FDA 510(k) clearance on 2023-10-13. The listed applicant is MiRus, LLC. The 510(k) number is K232481.

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

RIGEL™ 3DR Anterior Cervical Corpectomy System received FDA 510(k) clearance on 2023-10-13, under 510(k) number K232481.

Who is the listed applicant for RIGEL™ 3DR Anterior Cervical Corpectomy 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 Anterior Cervical Corpectomy System?

The FDA product code for RIGEL™ 3DR Anterior Cervical Corpectomy System is PLR.

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 SystemK232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemK232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation

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Related Devices (Code: PLR)

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.

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc.K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemAtlas Spine, Inc.K221542Galileo Vertebral Body Replacement DeviceBright SpineK212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.K211320CAPRI Corpectomy Cage SystemK2m, Inc.K192145Galileo Vertebral Body Replacement DeviceBright 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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