MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation— 510(k) K232154

Name: FDA 510(k) clearance K232154
Creator: U.S. Food and Drug Administration
Published: 2023-09-11

Substantially Equivalent

MiRus, LLC

FDA 510(k) clearance K232154 for MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation, Substantially Equivalent on 2023-09-11. Applicant: MiRus, LLC. Device class: 2.

Clearance details

Applicant: MiRus, LLC
Product code: Code OVD
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2023-07-20
Decision date: 2023-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OVD

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K262025 — Innovasis AxTiHA® Stand-Alone ALIF System +2 more2026-09-11
K261408 — SABER-XA System2026-08-03
K261809 — Interwedge® Standalone Lateral2026-07-31
K261353 — Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System2026-07-15
K260810 — Anteralign LS coverplate2026-06-10

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 OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.