APTUS® Coronoid 2.0
K-Number: K161861 · 2017-02-09
ApplicantMedartis AG
Decision Date2017-02-09
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
APTUS® Coronoid 2.0 is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2017-02-09 under approval number K161861. 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 APTUS® Coronoid 2.0?
APTUS® Coronoid 2.0 is a medical device that received FDA 510(k) clearance on 2017-02-09. It is manufactured by Medartis AG. The 510(k) number is K161861.
When was APTUS® Coronoid 2.0 approved by the FDA?
APTUS® Coronoid 2.0 received FDA 510(k) clearance on 2017-02-09, under approval number K161861.
What company makes APTUS® Coronoid 2.0?
APTUS® Coronoid 2.0 is manufactured by Medartis AG.
What is the FDA product code for APTUS® Coronoid 2.0?
The FDA product code for APTUS® Coronoid 2.0 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.