Omnia Medical Coupler-C Anterior Cervical Plate— 510(k) K223321

Name: FDA 510(k) clearance K223321
Creator: U.S. Food and Drug Administration
Published: 2023-03-13

Substantially Equivalent

Omnia Medical, LLC

FDA 510(k) clearance K223321 for Omnia Medical Coupler-C Anterior Cervical Plate, Substantially Equivalent on 2023-03-13. Applicant: Omnia Medical, LLC. Device class: 2.

Clearance details

Applicant: Omnia Medical, LLC
Product code: Code KWQ
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2022-10-31
Decision date: 2023-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Morgantown, WV, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KWQ

view all

K261309 — Palisades Buttress Plate System2026-07-16
K252776 — ARIES Anterior Cervical Plate Systems2026-05-14
K261112 — CastleLoc-P Anterior Cervical Plate System2026-05-06
K260570 — corra cervical plating system2026-04-22
K260697 — VyPlate Anterior Cervical Plate System2026-03-27

More clearances from Omnia Medical, LLC

view all

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

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.