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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 the device name listed in this FDA 510(k) record. The listed applicant is Medline Industires, LP. It received FDA 510(k) clearance on 2024-01-18 under 510(k) 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. The listed applicant is Medline Industires, LP. The 510(k) number is K234031.

When did Medline UNITE Ancillary Foot Recon Plating System receive FDA 510(k) clearance?

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

Who is the listed applicant for Medline UNITE Ancillary Foot Recon Plating System?

The FDA 510(k) record lists Medline Industires, LP as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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