# Omnia Medical, LLC

- Location (FDA's records): Morgantown,, WV
- FDA decisions: 11 (2017–2025): 11 510(k) clearances
- Product codes: KWQ (2), OVD (2), MAX (2), PLR (1), OUR (1), OVE (1), HWC (1), MQP (1)
- 510(k) review time since 2016: median 86 days, against 97 for FDA's reviews in the same codes and years (6 of 11 faster)
- Predicates its devices cite: 17 (3 its own); citations of its devices by later devices: 7 (3 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Globus Medical, Inc.: 2 (https://510kreport.com/company/globus-medical)
- Stryker Corp.: 1 (https://510kreport.com/company/stryker)
- Nu Vasive, Incorporated: 1 (https://510kreport.com/company/nu-vasive)
- Atlas Spine, Inc.: 1 (https://510kreport.com/company/atlas-spine)
- Sail Fusion, LLC: 1 (https://510kreport.com/company/sail-fusion)
- Synthes (Usa): 1 (https://510kreport.com/company/synthes-usa)
- SeaSpine Orthopedics Corporation: 1 (https://510kreport.com/company/seaspine-orthopedics)
- Seaspine, Inc.: 1 (https://510kreport.com/company/seaspine)

## Firms that cite its devices most
- Corelink, LLC: 1 (https://510kreport.com/company/corelink)
- Icotec AG: 1 (https://510kreport.com/company/icotec)
- Eminent Spine: 1 (https://510kreport.com/company/eminent-spine)
- Sync Surgical: 1 (https://510kreport.com/company/sync-surgical)

## Its most-cited devices
- K191778: Omnia Medical VBR (2019), cited by 3
- K203207: Omnia Medical TiBrid-SA (2020), cited by 1
- K242431: Omnia Medical PsiF DNA™ System (2025), cited by 1
- K190363: Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage (2020), cited by 1
- K172323: Omnia Medical VBR (2017), cited by 1

## Recent decisions
- K242431: Omnia Medical PsiF DNA™ System (Jun 6, 2025)
- K240623: Omnia Medical TiBrid™-SA System (Apr 24, 2024)
- K230424: Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System (Apr 12, 2023)
- K223321: Omnia Medical Coupler-C Anterior Cervical Plate (Mar 13, 2023)
- K212612: Omnia Medical TiBrid-SC (Nov 15, 2022)
- K203207: Omnia Medical TiBrid-SA (Dec 23, 2020)
- K192096: Omnia Medical Trauma Screws (Feb 27, 2020)
- K190363: Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage (Feb 21, 2020)

Source page: https://510kreport.com/company/omnia-medical