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FDA 510(k)

Medline UNITE Ancillary Foot Recon Plating System

K-Number: K234031 · 2024-01-18

ApplicantMedline Industires, LP
Decision Date2024-01-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE Ancillary Foot Recon Plating System is a medical device manufactured by Medline Industires, LP. It received FDA 510(k) clearance on 2024-01-18 under approval number K234031. 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 Ancillary Foot Recon Plating System?

Medline UNITE Ancillary Foot Recon Plating System is a medical device that received FDA 510(k) clearance on 2024-01-18. It is manufactured by Medline Industires, LP. The 510(k) number is K234031.

When was Medline UNITE Ancillary Foot Recon Plating System approved by the FDA?

Medline UNITE Ancillary Foot Recon Plating System received FDA 510(k) clearance on 2024-01-18, under approval number K234031.

What company makes Medline UNITE Ancillary Foot Recon Plating System?

Medline UNITE Ancillary Foot Recon Plating System is manufactured by Medline Industires, LP.

What is the FDA product code for Medline UNITE Ancillary Foot Recon Plating System?

The FDA product code for Medline UNITE Ancillary Foot Recon Plating 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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