FDA 510(k)

RIGEL 3DR Anterior Cervical Corpectomy System

K-Number: K232481 · 2023-10-13

Decision Date2023-10-13

Product CodePLR

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

RIGEL 3DR Anterior Cervical Corpectomy System is a medical device manufactured by MiRus, LLC. It received FDA 510(k) clearance on 2023-10-13 under approval 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. It is manufactured by MiRus, LLC. The 510(k) number is K232481.

When was RIGEL 3DR Anterior Cervical Corpectomy System approved by the FDA?

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

What company makes RIGEL 3DR Anterior Cervical Corpectomy System?

RIGEL 3DR Anterior Cervical Corpectomy System is manufactured by MiRus, LLC.

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.

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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.