Medartis APTUS® Ulna Plates
K-Number: K223853 · 2023-03-30
ApplicantMedartis AG
Decision Date2023-03-30
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Medartis APTUS® Ulna Plates is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2023-03-30 under approval number K223853. 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 Medartis APTUS® Ulna Plates?
Medartis APTUS® Ulna Plates is a medical device that received FDA 510(k) clearance on 2023-03-30. It is manufactured by Medartis AG. The 510(k) number is K223853.
When was Medartis APTUS® Ulna Plates approved by the FDA?
Medartis APTUS® Ulna Plates received FDA 510(k) clearance on 2023-03-30, under approval number K223853.
What company makes Medartis APTUS® Ulna Plates?
Medartis APTUS® Ulna Plates is manufactured by Medartis AG.
What is the FDA product code for Medartis APTUS® Ulna Plates?
The FDA product code for Medartis APTUS® Ulna Plates 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.