Omni Foot Plating System
K-Number: K180808 · 2018-05-22
ApplicantExtremity Medical, LLC
Decision Date2018-05-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Omni Foot Plating System is a medical device manufactured by Extremity Medical, LLC. It received FDA 510(k) clearance on 2018-05-22 under approval number K180808. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Omni Foot Plating System?
Omni Foot Plating System is a medical device that received FDA 510(k) clearance on 2018-05-22. It is manufactured by Extremity Medical, LLC. The 510(k) number is K180808.
When was Omni Foot Plating System approved by the FDA?
Omni Foot Plating System received FDA 510(k) clearance on 2018-05-22, under approval number K180808.
What company makes Omni Foot Plating System?
Omni Foot Plating System is manufactured by Extremity Medical, LLC.
What is the FDA product code for Omni Foot Plating System?
The FDA product code for Omni Foot Plating System is HRS.
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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.