Omnia Medical VBR
K-Number: K191778 · 2019-08-28
ApplicantOmnia Medical, LLC
Decision Date2019-08-28
Product CodePLR
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Omnia Medical VBR is a medical device manufactured by Omnia Medical, LLC. It received FDA 510(k) clearance on 2019-08-28 under approval number K191778. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Omnia Medical VBR?
Omnia Medical VBR is a medical device that received FDA 510(k) clearance on 2019-08-28. It is manufactured by Omnia Medical, LLC. The 510(k) number is K191778.
When was Omnia Medical VBR approved by the FDA?
Omnia Medical VBR received FDA 510(k) clearance on 2019-08-28, under approval number K191778.
What company makes Omnia Medical VBR?
Omnia Medical VBR is manufactured by Omnia Medical, LLC.
What is the FDA product code for Omnia Medical VBR?
The FDA product code for Omnia Medical VBR is PLR.
Other Devices by Omnia Medical, LLC
K172323Omnia 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
K212612Omnia Medical TiBrid-SC
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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.