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FDA 510(k)

Medline UNITE® MIS Foot Recon Screw System

K-Number: K241359 · 2024-08-02

ApplicantMedline Industries, LP
Decision Date2024-08-02
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE® MIS Foot Recon Screw System is a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2024-08-02 under approval number K241359. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline UNITE® MIS Foot Recon Screw System?

Medline UNITE® MIS Foot Recon Screw System is a medical device that received FDA 510(k) clearance on 2024-08-02. It is manufactured by Medline Industries, LP. The 510(k) number is K241359.

When was Medline UNITE® MIS Foot Recon Screw System approved by the FDA?

Medline UNITE® MIS Foot Recon Screw System received FDA 510(k) clearance on 2024-08-02, under approval number K241359.

What company makes Medline UNITE® MIS Foot Recon Screw System?

Medline UNITE® MIS Foot Recon Screw System is manufactured by Medline Industries, LP.

What is the FDA product code for Medline UNITE® MIS Foot Recon Screw System?

The FDA product code for Medline UNITE® MIS Foot Recon Screw System is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

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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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