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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 a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2022-09-27 under approval 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. It is manufactured by Medline Industries, LP. The 510(k) number is K221360.

When was Medline UNITE® Medial Malleolus Peg Plate System approved by the FDA?

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

What company makes Medline UNITE® Medial Malleolus Peg Plate System?

Medline UNITE® Medial Malleolus Peg Plate System is manufactured by Medline Industries, LP.

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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