Medline UNITE® Ankle Fracture Plating System

Plate, Fixation, Bone

MEDLINE, INDUSTRIES, INC.

The following data is part of a premarket notification filed by Medline, Industries, Inc. with the FDA for Medline Unite® Ankle Fracture Plating System.

Pre-market Notification Details

Device IDK162829
510k NumberK162829
Device Name:Medline UNITE® Ankle Fracture Plating System
ClassificationPlate, Fixation, Bone
Applicant MEDLINE, INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
ContactJennifer Mason
CorrespondentJennifer Mason
MEDLINE, INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein,  IL  60060
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-10-07
Decision Date2016-12-09
Summary:summary

Trademark Results [Medline UNITE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MEDLINE UNITE
MEDLINE UNITE
85921082 4653673 Live/Registered
Medline Industries, Inc.
2013-05-02
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