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 IDK081978
510k NumberK081978
Device Name:RELIANCE SPINAL SCREW SYSTEM
ClassificationOrthosis, Spinal Pedicle Fixation
Applicant Reliance Medical Systems, LLC 2647 CASSOWARY CIR Sandy,  UT  84092 -7116
ContactBret M Berry
CorrespondentBret M Berry
Reliance Medical Systems, LLC 2647 CASSOWARY CIR Sandy,  UT  84092 -7116
Product CodeMNI  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-11
Decision Date2009-03-26
Summary:summary

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