Medline Unite Mini Plates And Screws

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 Mini Plates And Screws.

Pre-market Notification Details

Device IDK181820
510k NumberK181820
Device Name:Medline Unite Mini Plates And Screws
ClassificationPlate, Fixation, Bone
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactJennifer Mason
CorrespondentJennifer Mason
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-09
Decision Date2018-11-01
Summary:summary

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