Dymaxeon Spine System

Thoracolumbosacral Pedicle Screw System

Back 2 Basics Direct, LLC

The following data is part of a premarket notification filed by Back 2 Basics Direct, Llc with the FDA for Dymaxeon Spine System.

Pre-market Notification Details

Device IDK192930
510k NumberK192930
Device Name:Dymaxeon Spine System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Back 2 Basics Direct, LLC 6701 Rockside Road, Suite 200 Independence,  OH  44131
ContactLou Keppler
CorrespondentKaren E Warden
BackRoads Consulting 12520 Heath Road Chesterland,  OH  44026
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-17
Decision Date2020-05-12

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