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FDA 510(k)

Arthrex FibuLock Nail System

K-Number: K252196 · 2026-03-05

ApplicantArthrex, Inc.
Decision Date2026-03-05
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex FibuLock Nail System is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2026-03-05 under approval number K252196. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex FibuLock Nail System?

Arthrex FibuLock Nail System is a medical device that received FDA 510(k) clearance on 2026-03-05. It is manufactured by Arthrex, Inc.. The 510(k) number is K252196.

When was Arthrex FibuLock Nail System approved by the FDA?

Arthrex FibuLock Nail System received FDA 510(k) clearance on 2026-03-05, under approval number K252196.

What company makes Arthrex FibuLock Nail System?

Arthrex FibuLock Nail System is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex FibuLock Nail System?

The FDA product code for Arthrex FibuLock Nail System is HSB.

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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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