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FDA 510(k)

Pantheon Medical Balanced Plating System

K-Number: K162154 · 2017-04-24

ApplicantPantheon Medical
Decision Date2017-04-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pantheon Medical Balanced Plating System is a medical device manufactured by Pantheon Medical. It received FDA 510(k) clearance on 2017-04-24 under approval number K162154. 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 Pantheon Medical Balanced Plating System?

Pantheon Medical Balanced Plating System is a medical device that received FDA 510(k) clearance on 2017-04-24. It is manufactured by Pantheon Medical. The 510(k) number is K162154.

When was Pantheon Medical Balanced Plating System approved by the FDA?

Pantheon Medical Balanced Plating System received FDA 510(k) clearance on 2017-04-24, under approval number K162154.

What company makes Pantheon Medical Balanced Plating System?

Pantheon Medical Balanced Plating System is manufactured by Pantheon Medical.

What is the FDA product code for Pantheon Medical Balanced Plating System?

The FDA product code for Pantheon Medical Balanced Plating System is 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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