APTUS Clavicle System
K-Number: K192984 · 2020-01-24
ApplicantMedartis AG
Decision Date2020-01-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
APTUS Clavicle System is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2020-01-24 under approval number K192984. 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 Clavicle System?
APTUS Clavicle System is a medical device that received FDA 510(k) clearance on 2020-01-24. It is manufactured by Medartis AG. The 510(k) number is K192984.
When was APTUS Clavicle System approved by the FDA?
APTUS Clavicle System received FDA 510(k) clearance on 2020-01-24, under approval number K192984.
What company makes APTUS Clavicle System?
APTUS Clavicle System is manufactured by Medartis AG.
What is the FDA product code for APTUS Clavicle System?
The FDA product code for APTUS Clavicle 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.