Arthrex 3.9 mm SwiveLock Anchor
K-Number: K230435 · 2023-03-17
ApplicantArthrex, Inc.
Decision Date2023-03-17
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Arthrex 3.9 mm SwiveLock Anchor is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2023-03-17 under approval number K230435. 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 Arthrex 3.9 mm SwiveLock Anchor?
Arthrex 3.9 mm SwiveLock Anchor is a medical device that received FDA 510(k) clearance on 2023-03-17. It is manufactured by Arthrex, Inc.. The 510(k) number is K230435.
When was Arthrex 3.9 mm SwiveLock Anchor approved by the FDA?
Arthrex 3.9 mm SwiveLock Anchor received FDA 510(k) clearance on 2023-03-17, under approval number K230435.
What company makes Arthrex 3.9 mm SwiveLock Anchor?
Arthrex 3.9 mm SwiveLock Anchor is manufactured by Arthrex, Inc..
What is the FDA product code for Arthrex 3.9 mm SwiveLock Anchor?
The FDA product code for Arthrex 3.9 mm SwiveLock 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.