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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Omnia Medical, LLC. It received FDA 510(k) clearance on 2019-02-06 under 510(k) 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. The listed applicant is Omnia Medical, LLC. The 510(k) number is K183659.

When did Omnia Medical Rotary PLIF System receive FDA 510(k) clearance?

Omnia Medical Rotary PLIF System received FDA 510(k) clearance on 2019-02-06, under 510(k) number K183659.

Who is the listed applicant for Omnia Medical Rotary PLIF System?

The FDA 510(k) record lists Omnia Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Omnia Medical Rotary PLIF System?

The FDA product code for Omnia Medical Rotary PLIF System is MAX.

Other records listing Omnia Medical, LLC as applicant

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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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