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FDA 510(k)

Omnia Medical TiBrid-SC

K-Number: K212612 · 2022-11-15

ApplicantOmnia Medical, LLC
Decision Date2022-11-15
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Omnia Medical TiBrid-SC is a medical device manufactured by Omnia Medical, LLC. It received FDA 510(k) clearance on 2022-11-15 under approval number K212612. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omnia Medical TiBrid-SC?

Omnia Medical TiBrid-SC is a medical device that received FDA 510(k) clearance on 2022-11-15. It is manufactured by Omnia Medical, LLC. The 510(k) number is K212612.

When was Omnia Medical TiBrid-SC approved by the FDA?

Omnia Medical TiBrid-SC received FDA 510(k) clearance on 2022-11-15, under approval number K212612.

What company makes Omnia Medical TiBrid-SC?

Omnia Medical TiBrid-SC is manufactured by Omnia Medical, LLC.

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

The FDA product code for Omnia Medical TiBrid-SC is OVE.

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.

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