APTUS Wrist Spanning Plates 2.5
K-Number: K191848 · 2019-09-30
ApplicantMedartis AG
Decision Date2019-09-30
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
APTUS Wrist Spanning Plates 2.5 is a medical device manufactured by Medartis AG. It received FDA 510(k) clearance on 2019-09-30 under approval number K191848. 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 Wrist Spanning Plates 2.5?
APTUS Wrist Spanning Plates 2.5 is a medical device that received FDA 510(k) clearance on 2019-09-30. It is manufactured by Medartis AG. The 510(k) number is K191848.
When was APTUS Wrist Spanning Plates 2.5 approved by the FDA?
APTUS Wrist Spanning Plates 2.5 received FDA 510(k) clearance on 2019-09-30, under approval number K191848.
What company makes APTUS Wrist Spanning Plates 2.5?
APTUS Wrist Spanning Plates 2.5 is manufactured by Medartis AG.
What is the FDA product code for APTUS Wrist Spanning Plates 2.5?
The FDA product code for APTUS Wrist Spanning Plates 2.5 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.