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FDA 510(k)

Medline UNITE® Ankle Fracture Plating System

K-Number: K162829 · 2016-12-09

ApplicantMedline Industries, Inc.
Decision Date2016-12-09
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Medline UNITE® Ankle Fracture Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2016-12-09 under 510(k) number K162829. 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 Fracture Plating System?

Medline UNITE® Ankle Fracture Plating System is a medical device that received FDA 510(k) clearance on 2016-12-09. The listed applicant is Medline Industries, Inc.. The 510(k) number is K162829.

When did Medline UNITE® Ankle Fracture Plating System receive FDA 510(k) clearance?

Medline UNITE® Ankle Fracture Plating System received FDA 510(k) clearance on 2016-12-09, under 510(k) number K162829.

Who is the listed applicant for Medline UNITE® Ankle Fracture Plating System?

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

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

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

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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.

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 KGK261351SALGINA 2.5mm Distal Radius SystemBonebridge 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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