FDA 510(k)

Arthrex TightRope Soft Button, RT

K-Number: K250424 · 2025-03-11

Decision Date2025-03-11

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Arthrex TightRope Soft Button, RT is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2025-03-11 under approval number K250424. 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 Arthrex TightRope Soft Button, RT?

Arthrex TightRope Soft Button, RT is a medical device that received FDA 510(k) clearance on 2025-03-11. It is manufactured by Arthrex, Inc.. The 510(k) number is K250424.

When was Arthrex TightRope Soft Button, RT approved by the FDA?

Arthrex TightRope Soft Button, RT received FDA 510(k) clearance on 2025-03-11, under approval number K250424.

What company makes Arthrex TightRope Soft Button, RT?

Arthrex TightRope Soft Button, RT is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex TightRope Soft Button, RT?

The FDA product code for Arthrex TightRope Soft Button, RT is MBI.

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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.