RIGEL 3DR Anterior Cervical Corpectomy System— 510(k) K232481

Name: FDA 510(k) clearance K232481
Creator: U.S. Food and Drug Administration
Published: 2023-10-13

Substantially Equivalent

MiRus, LLC

FDA 510(k) clearance K232481 for RIGEL 3DR Anterior Cervical Corpectomy System, Substantially Equivalent on 2023-10-13. Applicant: MiRus, LLC. Device class: 2.

Clearance details

Applicant: MiRus, LLC
Product code: Code PLR
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2023-08-16
Decision date: 2023-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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K212126 — MediExpand Cervical Expandable VBR System2022-04-04
K211320 — CAPRI Corpectomy Cage System2022-02-24

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K253444 — EUROPA Posterior Cervical Fusion Navigated Instruments2026-03-18
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K242516 — EUROPA Posterior Cervical Fusion System2024-11-19
K241175 — MiRus MoRe Lumbar Plating System2024-05-17
K232348 — RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System2023-10-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.