Arthrex Minimally Invasive Ankle Fusion Plate
K-Number: K190953 · 2019-10-16
ApplicantArthrex, Inc.
Decision Date2019-10-16
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Arthrex Minimally Invasive Ankle Fusion Plate is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2019-10-16 under approval number K190953. 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 Arthrex Minimally Invasive Ankle Fusion Plate?
Arthrex Minimally Invasive Ankle Fusion Plate is a medical device that received FDA 510(k) clearance on 2019-10-16. It is manufactured by Arthrex, Inc.. The 510(k) number is K190953.
When was Arthrex Minimally Invasive Ankle Fusion Plate approved by the FDA?
Arthrex Minimally Invasive Ankle Fusion Plate received FDA 510(k) clearance on 2019-10-16, under approval number K190953.
What company makes Arthrex Minimally Invasive Ankle Fusion Plate?
Arthrex Minimally Invasive Ankle Fusion Plate is manufactured by Arthrex, Inc..
What is the FDA product code for Arthrex Minimally Invasive Ankle Fusion Plate?
The FDA product code for Arthrex Minimally Invasive Ankle Fusion Plate 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.