Omnia Medical Trauma Screws
K-Number: K192096 · 2020-02-27
ApplicantOmnia Medical, LLC
Decision Date2020-02-27
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Omnia Medical Trauma Screws is a medical device manufactured by Omnia Medical, LLC. It received FDA 510(k) clearance on 2020-02-27 under approval number K192096. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Omnia Medical Trauma Screws?
Omnia Medical Trauma Screws is a medical device that received FDA 510(k) clearance on 2020-02-27. It is manufactured by Omnia Medical, LLC. The 510(k) number is K192096.
When was Omnia Medical Trauma Screws approved by the FDA?
Omnia Medical Trauma Screws received FDA 510(k) clearance on 2020-02-27, under approval number K192096.
What company makes Omnia Medical Trauma Screws?
Omnia Medical Trauma Screws is manufactured by Omnia Medical, LLC.
What is the FDA product code for Omnia Medical Trauma Screws?
The FDA product code for Omnia Medical Trauma Screws is HWC. This falls under the Cardiovascular category.
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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.