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FDA 510(k)

Knotless TensionTight Button Implant System

K-Number: K202444 · 2020-11-17

ApplicantArthrex, Inc.
Decision Date2020-11-17
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Knotless TensionTight Button Implant System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2020-11-17 under approval number K202444. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Knotless TensionTight Button Implant System?

Knotless TensionTight Button Implant System is a medical device that received FDA 510(k) clearance on 2020-11-17. It is manufactured by Arthrex, Inc.. The 510(k) number is K202444.

When was Knotless TensionTight Button Implant System approved by the FDA?

Knotless TensionTight Button Implant System received FDA 510(k) clearance on 2020-11-17, under approval number K202444.

What company makes Knotless TensionTight Button Implant System?

Knotless TensionTight Button Implant System is manufactured by Arthrex, Inc..

What is the FDA product code for Knotless TensionTight Button Implant System?

The FDA product code for Knotless TensionTight Button Implant System is MBI.

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Related PubMed Literature

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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.

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