Fixone Biocomposite Anchor
K-Number: K192484 · 2020-03-11
ApplicantAju Pharm Co., Ltd.
Decision Date2020-03-11
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Fixone Biocomposite Anchor is a medical device manufactured by Aju Pharm Co., Ltd.. It received FDA 510(k) clearance on 2020-03-11 under approval number K192484. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Fixone Biocomposite Anchor?
Fixone Biocomposite Anchor is a medical device that received FDA 510(k) clearance on 2020-03-11. It is manufactured by Aju Pharm Co., Ltd.. The 510(k) number is K192484.
When was Fixone Biocomposite Anchor approved by the FDA?
Fixone Biocomposite Anchor received FDA 510(k) clearance on 2020-03-11, under approval number K192484.
What company makes Fixone Biocomposite Anchor?
Fixone Biocomposite Anchor is manufactured by Aju Pharm Co., Ltd..
What is the FDA product code for Fixone Biocomposite Anchor?
The FDA product code for Fixone Biocomposite Anchor is MAI.
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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.