Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System— 510(k) K230424

Substantially Equivalent

Omnia Medical, LLC

FDA 510(k) clearance K230424 for Omnia Medical Coupler-A Anterior Lumbar Plate System; Omnia Medical Coupler-L Lateral Lumbar Plate System, Substantially Equivalent on 2023-04-12. Applicant: Omnia Medical, LLC.

Clearance details

Applicant: Omnia Medical, LLC
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2023-02-17
Decision date: 2023-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morgantown, WV, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.