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FDA 510(k)

Medline UNITE® Medial Malleolus Peg Plate System

K-Number: K221360 · 2022-09-27

ApplicantMedline Industries, LP
Decision Date2022-09-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE® Medial Malleolus Peg Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, LP. It received FDA 510(k) clearance on 2022-09-27 under 510(k) number K221360. 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 Medline UNITE® Medial Malleolus Peg Plate System?

Medline UNITE® Medial Malleolus Peg Plate System is a medical device that received FDA 510(k) clearance on 2022-09-27. The listed applicant is Medline Industries, LP. The 510(k) number is K221360.

When did Medline UNITE® Medial Malleolus Peg Plate System receive FDA 510(k) clearance?

Medline UNITE® Medial Malleolus Peg Plate System received FDA 510(k) clearance on 2022-09-27, under 510(k) number K221360.

Who is the listed applicant for Medline UNITE® Medial Malleolus Peg Plate System?

The FDA 510(k) record lists Medline Industries, LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medline UNITE® Medial Malleolus Peg Plate System?

The FDA product code for Medline UNITE® Medial Malleolus Peg Plate 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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