Reliance Cervical IBF System

Intervertebral Fusion Device With Bone Graft, Cervical

Reliance Medical Systems, LLC

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

Pre-market Notification Details

Device IDK142269
510k NumberK142269
Device Name:Reliance Cervical IBF System
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Reliance Medical Systems, LLC 545 West 500 South, Suite 100 Bountiful,  UT  84010
ContactBret M Berry
CorrespondentBret M Berry
Reliance Medical Systems, LLC PO Box 1693 Bountiful,  UT  84011
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-15
Decision Date2015-06-09
Summary:summary

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