Omnia Medical PsiF DNA System— 510(k) K242431

Name: FDA 510(k) clearance K242431
Creator: U.S. Food and Drug Administration
Published: 2025-06-06

Substantially Equivalent

Omnia Medical, LLC

FDA 510(k) clearance K242431 for Omnia Medical PsiF DNA System, Substantially Equivalent on 2025-06-06. Applicant: Omnia Medical, LLC. Device class: 2.

Clearance details

Applicant: Omnia Medical, LLC
Product code: Code OUR
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2024-08-16
Decision date: 2025-06-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morgantown,, WV, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OUR

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K261381 — TiLink-L SI Joint Fusion System2026-08-24
K260477 — CATAMARAN SI Joint Fusion System2026-04-08
K253488 — iFuse INTRA Ti Implant System2026-02-11
K253611 — Falco Fusion System2026-01-29
K252834 — Sacroiliac Joint Truss System (SJTS)2026-01-28

More clearances from Omnia Medical, LLC

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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
K212612 — Omnia Medical TiBrid-SC2022-11-15
K203207 — Omnia Medical TiBrid-SA2020-12-23

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

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.