RELIANCE SPINAL SCREW SYSTEM

Orthosis, Spinal Pedicle Fixation

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 IDK123521
510k NumberK123521
Device Name:RELIANCE SPINAL SCREW SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant Reliance Medical Systems, LLC P.O. BOX 1693 Bountiful,  UT  84010
ContactBret M Berry
CorrespondentBret M Berry
Reliance Medical Systems, LLC P.O. BOX 1693 Bountiful,  UT  84010
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-15
Decision Date2013-02-07
Summary:summary

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