FDA 510(k)

Omnia Medical TiBrid-SA System

K-Number: K240623 · 2024-04-24

Decision Date2024-04-24

Product CodeOVD

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Omnia Medical TiBrid-SA System is a medical device manufactured by Omnia Medical, LLC. It received FDA 510(k) clearance on 2024-04-24 under approval number K240623. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omnia Medical TiBrid-SA System?

Omnia Medical TiBrid-SA System is a medical device that received FDA 510(k) clearance on 2024-04-24. It is manufactured by Omnia Medical, LLC. The 510(k) number is K240623.

When was Omnia Medical TiBrid-SA System approved by the FDA?

Omnia Medical TiBrid-SA System received FDA 510(k) clearance on 2024-04-24, under approval number K240623.

What company makes Omnia Medical TiBrid-SA System?

Omnia Medical TiBrid-SA System is manufactured by Omnia Medical, LLC.

What is the FDA product code for Omnia Medical TiBrid-SA System?

The FDA product code for Omnia Medical TiBrid-SA System is OVD.

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Related PubMed Literature

PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025)

Other Devices by Omnia Medical, LLC

K172323Omnia Medical VBR K191778Omnia Medical VBR K183659Omnia Medical Rotary PLIF System K203207Omnia Medical TiBrid-SA K192096Omnia Medical Trauma Screws K190363Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.