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FDA 510(k)

Clavicle Fixation System

K-Number: K254288 · 2026-03-23

ApplicantSkeletal Dynamics, Inc.
Decision Date2026-03-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Clavicle Fixation System is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2026-03-23 under approval number K254288. 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 Clavicle Fixation System?

Clavicle Fixation System is a medical device that received FDA 510(k) clearance on 2026-03-23. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K254288.

When was Clavicle Fixation System approved by the FDA?

Clavicle Fixation System received FDA 510(k) clearance on 2026-03-23, under approval number K254288.

What company makes Clavicle Fixation System?

Clavicle Fixation System is manufactured by Skeletal Dynamics, Inc..

What is the FDA product code for Clavicle Fixation System?

The FDA product code for Clavicle Fixation System is HRS.

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Other Devices by Skeletal Dynamics, Inc.

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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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