Fixone Biocomposite Anchor
K-Number: K230892 · 2023-06-09
ApplicantAju Pharm Co., Ltd.
Decision Date2023-06-09
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 2023-06-09 under approval number K230892. 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 2023-06-09. It is manufactured by Aju Pharm Co., Ltd.. The 510(k) number is K230892.
When was Fixone Biocomposite Anchor approved by the FDA?
Fixone Biocomposite Anchor received FDA 510(k) clearance on 2023-06-09, under approval number K230892.
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.