FDA 510(k)

Arthrex Humeral Nails

K-Number: K252016 · 2026-03-20

Decision Date2026-03-20

Product CodeHSB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Arthrex Humeral Nails is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2026-03-20 under approval 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. It is manufactured by Arthrex, Inc.. The 510(k) number is K252016.

When was Arthrex Humeral Nails approved by the FDA?

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

What company makes Arthrex Humeral Nails?

Arthrex Humeral Nails is manufactured by Arthrex, Inc..

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)

K161264TRIGEN Low Profile Bone ScrewsSmith & Nephew, Inc. K160545GAP ENDO-EXO MEDULLARY SYSTEMPega Medical, Inc. K161254Renovo Life Small Bone IM Nail SystemRenovo Life, LLC K160167DePuy Synthes TFNA Augmentation SystemSynthes (USA) Products, LLC K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. K160267PRECICE Trauma Nail SystemEllipse Technologies, Incorporated

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.