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FDA 510(k)

Medline UNITE® Ankle Fusion Plating System

K-Number: K222665 · 2023-01-25

ApplicantMedline Industries, Inc.
Decision Date2023-01-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE® Ankle Fusion Plating System is a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2023-01-25 under approval number K222665. 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® Ankle Fusion Plating System?

Medline UNITE® Ankle Fusion Plating System is a medical device that received FDA 510(k) clearance on 2023-01-25. It is manufactured by Medline Industries, Inc.. The 510(k) number is K222665.

When was Medline UNITE® Ankle Fusion Plating System approved by the FDA?

Medline UNITE® Ankle Fusion Plating System received FDA 510(k) clearance on 2023-01-25, under approval number K222665.

What company makes Medline UNITE® Ankle Fusion Plating System?

Medline UNITE® Ankle Fusion Plating System is manufactured by Medline Industries, Inc..

What is the FDA product code for Medline UNITE® Ankle Fusion Plating System?

The FDA product code for Medline UNITE® Ankle Fusion Plating System is HRS.

Related Clinical Trials

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Other Devices by Medline Industries, Inc.

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Related Devices (Code: HRS)

K163086VLP MINI-MOD 2.0mm Column PlatesSmith & Nephew, Inc. K162829Medline UNITE® Ankle Fracture Plating SystemMedline Industries, Inc. K162974Biomet Microfixation RibFix Blu Thoracic Fixation SystemBiomet Microfixation K163007Biomet Microfixation SternaLock 360 Sternal Closure SystemBiomet Microfixation K161696aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5Aap Implantate AG K161747LOQTEQ® VA Distal Tibia Plate System: LOQTEQ® VA Distal Medial Tibia Plate 3.5; LOQTEQ® VA Distal Anterolateral Tibia Plate 3.5; LOQTEQ® VA Distal Fibula Plate 2.7/3.5Aap Implantate AG

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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