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FDA 510(k)

ArthroTAK Tendon Anchor Kit

K-Number: K252635 · 2026-05-01

ApplicantArthroTAK, LLC
Decision Date2026-05-01
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ArthroTAK Tendon Anchor Kit is a medical device manufactured by ArthroTAK, LLC. It received FDA 510(k) clearance on 2026-05-01 under approval number K252635. 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 ArthroTAK Tendon Anchor Kit?

ArthroTAK Tendon Anchor Kit is a medical device that received FDA 510(k) clearance on 2026-05-01. It is manufactured by ArthroTAK, LLC. The 510(k) number is K252635.

When was ArthroTAK Tendon Anchor Kit approved by the FDA?

ArthroTAK Tendon Anchor Kit received FDA 510(k) clearance on 2026-05-01, under approval number K252635.

What company makes ArthroTAK Tendon Anchor Kit?

ArthroTAK Tendon Anchor Kit is manufactured by ArthroTAK, LLC.

What is the FDA product code for ArthroTAK Tendon Anchor Kit?

The FDA product code for ArthroTAK Tendon Anchor Kit is MBI.

Related Devices (Code: MBI)

K261363Y-Knotless™ Flex AnchorsCONMED Corporation K253027Anchor with Fiber Wire and Disposable InserterOrtobio S.A.

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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