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FDA 510(k)

Wrist Fracture System

K-Number: K251732 · 2026-02-12

Decision Date2026-02-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Wrist Fracture System is a medical device manufactured by Met One Technologies, LLC. It received FDA 510(k) clearance on 2026-02-12 under approval number K251732. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wrist Fracture System?

Wrist Fracture System is a medical device that received FDA 510(k) clearance on 2026-02-12. It is manufactured by Met One Technologies, LLC. The 510(k) number is K251732.

When was Wrist Fracture System approved by the FDA?

Wrist Fracture System received FDA 510(k) clearance on 2026-02-12, under approval number K251732.

What company makes Wrist Fracture System?

Wrist Fracture System is manufactured by Met One Technologies, LLC.

What is the FDA product code for Wrist Fracture System?

The FDA product code for Wrist Fracture System is HRS.

Related Clinical Trials

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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.