Omnia Medical Rotary PLIF System
K-Number: K183659 · 2019-02-06
ApplicantOmnia Medical, LLC
Decision Date2019-02-06
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Omnia Medical Rotary PLIF System is a medical device manufactured by Omnia Medical, LLC. It received FDA 510(k) clearance on 2019-02-06 under approval number K183659. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Omnia Medical Rotary PLIF System?
Omnia Medical Rotary PLIF System is a medical device that received FDA 510(k) clearance on 2019-02-06. It is manufactured by Omnia Medical, LLC. The 510(k) number is K183659.
When was Omnia Medical Rotary PLIF System approved by the FDA?
Omnia Medical Rotary PLIF System received FDA 510(k) clearance on 2019-02-06, under approval number K183659.
What company makes Omnia Medical Rotary PLIF System?
Omnia Medical Rotary PLIF System is manufactured by Omnia Medical, LLC.
What is the FDA product code for Omnia Medical Rotary PLIF System?
The FDA product code for Omnia Medical Rotary PLIF System is MAX.
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Other Devices by Omnia Medical, LLC
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K191778Omnia Medical VBR
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.