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Omnia Medical Coupler-A Anterior Lumbar Plate System - Omnia Medical Coupler-A™ Anterior Lumbar Plate System
FDA 510(k)Class II (US FDA 510(k))
510(k) K230424
Identifiers
- 510(k) Number
- K230424 FDA 510(k)
- FDA Product Code
- KWQ FDA 510(k)
- Models / Variants
- Omnia Medical Coupler-A™ Anterior Lumbar Plate System FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3060 FDA 510(k)
- Regulation Number
- 888.3060 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Omnia Medical Coupler-A Anterior Lumbar Plate System - Omnia Medical Coupler-A™ Anterior Lumbar Plate System by Omnia Medical, Llc — Class II — FDA_510K…
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230424 | Class II | Active |
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Manufacturer
- Manufacturer
- Omnia Medical, Llc
Sources (1)
- FDA 510(k) K230424 24 fields · synced Jun 18, 2026