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FDA 510(k)

Arthrex Humeral Nails

K-Number: K252016 · 2026-03-20

ApplicantArthrex, Inc.
Decision Date2026-03-20
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex Humeral Nails is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2026-03-20 under 510(k) number K252016. 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 Humeral Nails?

Arthrex Humeral Nails is a medical device that received FDA 510(k) clearance on 2026-03-20. The listed applicant is Arthrex, Inc.. The 510(k) number is K252016.

When did Arthrex Humeral Nails receive FDA 510(k) clearance?

Arthrex Humeral Nails received FDA 510(k) clearance on 2026-03-20, under 510(k) number K252016.

Who is the listed applicant for Arthrex Humeral Nails?

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

What is the FDA product code for Arthrex Humeral Nails?

The FDA product code for Arthrex Humeral Nails is HSB.

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Related Devices (Code: 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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