Medline UNITE REFLEX Nitinol Staple System

Staple, 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 Reflex Nitinol Staple System.

Pre-market Notification Details

Device IDK210482
510k NumberK210482
Device Name:Medline UNITE REFLEX Nitinol Staple System
ClassificationStaple, 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 CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-19
Decision Date2021-04-22

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