RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System— 510(k) K232348

Name: FDA 510(k) clearance K232348
Creator: U.S. Food and Drug Administration
Published: 2023-10-27

Substantially Equivalent

MiRus, LLC

FDA 510(k) clearance K232348 for RIGEL 3DR Standalone Anterior Cervical Interbody Fusion System, Substantially Equivalent on 2023-10-27. Applicant: MiRus, LLC. Device class: 2.

Clearance details

Applicant: MiRus, LLC
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2023-08-07
Decision date: 2023-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVE

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K261882 — Pisces-SC Standalone Cervical Interbody System2026-08-21
K261451 — ZSAlign Cervical Interbody System2026-07-31
K262094 — E3D-C Interbody System2026-07-22
K261279 — DeltaNEC Interbody System2026-06-22
K252982 — CONDUIT ZERO-P VA Secured Spacer System2026-06-18

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
K232481 — RIGEL 3DR Anterior Cervical Corpectomy System2023-10-13

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.