SOLITAIRE-C CERVICAL SPACER SYSTEM

Intervertebral Fusion Device With Integrated Fixation, Cervical

EBI, LLC

The following data is part of a premarket notification filed by Ebi, Llc with the FDA for Solitaire-c Cervical Spacer System.

Pre-market Notification Details

Device IDK113796
510k NumberK113796
Device Name:SOLITAIRE-C CERVICAL SPACER SYSTEM
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant EBI, LLC 399 Jefferson Rd Parsippany,  NJ  07054
ContactMargaret Crowe
CorrespondentMargaret Crowe
EBI, LLC 399 Jefferson Rd Parsippany,  NJ  07054
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-23
Decision Date2012-04-26
Summary:summary

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