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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 the device name listed in this FDA 510(k) record. The listed applicant is Met One Technologies, LLC. It received FDA 510(k) clearance on 2026-02-12 under 510(k) 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. The listed applicant is Met One Technologies, LLC. The 510(k) number is K251732.

When did Wrist Fracture System receive FDA 510(k) clearance?

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

Who is the listed applicant for Wrist Fracture System?

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

What is the FDA product code for Wrist Fracture System?

The FDA product code for Wrist Fracture System is HRS.

Other records listing Met One Technologies, LLC as applicant

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.

View all 7 devices →

Related Devices (Code: HRS)

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.

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.