Reliance Interspinous Plate System

Spinous Process Plate

Reliance Medical Systems, LLC

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

Pre-market Notification Details

Device IDK142217
510k NumberK142217
Device Name:Reliance Interspinous Plate System
ClassificationSpinous Process Plate
Applicant Reliance Medical Systems, LLC 545 West 500 South, Suite 100 Bountiful,  UT  84010
ContactJeremy Alsup
CorrespondentMeredith L May
EMPIRICAL TESTING CORPORATION 4628 NORTHPARK DRIVE Colorado Springs,  CO  80918
Product CodePEK  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-12
Decision Date2015-04-02
Summary:summary

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