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FDA 510(k)

TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM

K-Number: K200575 · 2021-07-09

ApplicantTruemed Group, LLC
Decision Date2021-07-09
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Truemed Group, LLC. It received FDA 510(k) clearance on 2021-07-09 under 510(k) number K200575. 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 TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM?

TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM is a medical device that received FDA 510(k) clearance on 2021-07-09. The listed applicant is Truemed Group, LLC. The 510(k) number is K200575.

When did TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM receive FDA 510(k) clearance?

TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM received FDA 510(k) clearance on 2021-07-09, under 510(k) number K200575.

Who is the listed applicant for TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM?

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

What is the FDA product code for TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM?

The FDA product code for TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM is HRS.

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Related Devices (Code: HRS)

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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.

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