RIGEL 3DR Anterior Cervical Interbody Fusion System— 510(k) K200685

Name: FDA 510(k) clearance K200685
Creator: U.S. Food and Drug Administration
Published: 2020-06-11

Substantially Equivalent

MiRus, LLC

FDA 510(k) clearance K200685 for RIGEL 3DR Anterior Cervical Interbody Fusion System, Substantially Equivalent on 2020-06-11. Applicant: MiRus, LLC. Device class: 2.

Clearance details

Applicant: MiRus, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2020-03-16
Decision date: 2020-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODP

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K262595 — VariLift-C Cervical Interbody Fusion System2026-08-26
K262489 — BluEX Cervical Expandable Cage System2026-08-18
K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from MiRus, LLC

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K253444 — EUROPA Posterior Cervical Fusion Navigated Instruments2026-03-18
K252733 — ATLAS Expandable Osteotomy Wedge System2026-02-19
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

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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