Medline UNITE Jones Fracture Screw System

Screw, Fixation, Bone

Medline Industires, Inc.

The following data is part of a premarket notification filed by Medline Industires, Inc. with the FDA for Medline Unite Jones Fracture Screw System.

Pre-market Notification Details

Device IDK201319
510k NumberK201319
Device Name:Medline UNITE Jones Fracture Screw System
ClassificationScrew, Fixation, Bone
Applicant Medline Industires, Inc. Three Lakes Drive Northfield,  IL  60030
ContactJennifer Mason
CorrespondentJennifer Mason
Medline Industires, Inc. Three Lakes Drive Northfield,  IL  60030
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-18
Decision Date2020-06-17

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