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FDA 510(k)

Distal Radius Plating System

K-Number: K162635 · 2016-10-21

ApplicantMiami Device Solutions, LLC
Decision Date2016-10-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Distal Radius Plating System is a medical device manufactured by Miami Device Solutions, LLC. It received FDA 510(k) clearance on 2016-10-21 under approval number K162635. 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 Distal Radius Plating System?

Distal Radius Plating System is a medical device that received FDA 510(k) clearance on 2016-10-21. It is manufactured by Miami Device Solutions, LLC. The 510(k) number is K162635.

When was Distal Radius Plating System approved by the FDA?

Distal Radius Plating System received FDA 510(k) clearance on 2016-10-21, under approval number K162635.

What company makes Distal Radius Plating System?

Distal Radius Plating System is manufactured by Miami Device Solutions, LLC.

What is the FDA product code for Distal Radius Plating System?

The FDA product code for Distal Radius Plating System is HRS.

Related Clinical Trials

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Other Devices by Miami Device Solutions, LLC

K161292Distal Radius Plating System K161058Cannulated Screw K172786MDS Plating System K162898Olecranon Plating System K182810Distal Radius Plating System

Related Devices (Code: HRS)

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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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