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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 the device name listed in this FDA 510(k) record. The listed applicant is ArthroTAK, LLC. It received FDA 510(k) clearance on 2026-05-01 under 510(k) 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. The listed applicant is ArthroTAK, LLC. The 510(k) number is K252635.

When did ArthroTAK Tendon Anchor Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for ArthroTAK Tendon Anchor Kit?

The FDA 510(k) record lists ArthroTAK, LLC as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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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