Reliance Spinal Screw System

Thoracolumbosacral Pedicle Screw System

Reliance Medical Systems, LLC

The following data is part of a premarket notification filed by Reliance Medical Systems, Llc with the FDA for Reliance Spinal Screw System.

Pre-market Notification Details

Device IDK210874
510k NumberK210874
Device Name:Reliance Spinal Screw System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Reliance Medical Systems, LLC 545 West 500 South, Suite 100 Bountiful,  UT  84010
ContactBret M Berry
CorrespondentBret M Berry
Reliance Medical Systems, LLC 545 West 500 South, Suite 100 Bountiful,  UT  84010
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-24
Decision Date2021-05-13

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