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FDA 510(k)

Medline UNITE Calcaneal Fracture Plating System

K-Number: K213567 · 2022-03-02

ApplicantMedline Industries, LP
Decision Date2022-03-02
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE Calcaneal Fracture Plating System is a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2022-03-02 under approval number K213567. 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 Calcaneal Fracture Plating System?

Medline UNITE Calcaneal Fracture Plating System is a medical device that received FDA 510(k) clearance on 2022-03-02. It is manufactured by Medline Industries, LP. The 510(k) number is K213567.

When was Medline UNITE Calcaneal Fracture Plating System approved by the FDA?

Medline UNITE Calcaneal Fracture Plating System received FDA 510(k) clearance on 2022-03-02, under approval number K213567.

What company makes Medline UNITE Calcaneal Fracture Plating System?

Medline UNITE Calcaneal Fracture Plating System is manufactured by Medline Industries, LP.

What is the FDA product code for Medline UNITE Calcaneal Fracture Plating System?

The FDA product code for Medline UNITE Calcaneal Fracture Plating System is HRS.

Related Clinical Trials

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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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