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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 a medical device manufactured by Medline Industries, Inc.. It received FDA 510(k) clearance on 2016-12-09 under approval 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. It is manufactured by Medline Industries, Inc.. The 510(k) number is K162829.

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

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

What company makes Medline UNITE® Ankle Fracture Plating System?

Medline UNITE® Ankle Fracture Plating System is manufactured by Medline Industries, Inc..

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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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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