Omnia Medical TiBrid-SC— 510(k) K212612

Name: FDA 510(k) clearance K212612
Creator: U.S. Food and Drug Administration
Published: 2022-11-15

Substantially Equivalent

Omnia Medical, LLC

FDA 510(k) clearance K212612 for Omnia Medical TiBrid-SC, Substantially Equivalent on 2022-11-15. Applicant: Omnia Medical, LLC. Device class: 2.

Clearance details

Applicant: Omnia Medical, LLC
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2021-08-17
Decision date: 2022-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morgantown,, WV, US

Download summary PDF View on FDA.gov ↗

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More clearances from Omnia Medical, LLC

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K242431 — Omnia Medical PsiF DNA System2025-06-06
K240623 — Omnia Medical TiBrid-SA System2024-04-24
K230424 — Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System2023-04-12
K223321 — Omnia Medical Coupler-C Anterior Cervical Plate2023-03-13
K203207 — Omnia Medical TiBrid-SA2020-12-23

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.