Medline UNITE REFLEX Dynamic Discs

Washer, Bolt Nut

Medline Industries, Inc.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Unite Reflex Dynamic Discs.

Pre-market Notification Details

Device IDK211612
510k NumberK211612
Device Name:Medline UNITE REFLEX Dynamic Discs
ClassificationWasher, Bolt Nut
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactJennifer Mason
CorrespondentJennifer Mason
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodeHTN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-26
Decision Date2021-12-10

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