Z-LINK CERVICAL

Intervertebral Fusion Device With Integrated Fixation, Cervical

ZAVATION, LLC

The following data is part of a premarket notification filed by Zavation, Llc with the FDA for Z-link Cervical.

Pre-market Notification Details

Device IDK141005
510k NumberK141005
Device Name:Z-LINK CERVICAL
ClassificationIntervertebral Fusion Device With Integrated Fixation, Cervical
Applicant ZAVATION, LLC 400 LIBERTY PARK Flowood,  MS  39232
ContactJohn Walker
CorrespondentJohn Walker
ZAVATION, LLC 400 LIBERTY PARK Flowood,  MS  39232
Product CodeOVE  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-18
Decision Date2014-08-07
Summary:summary

NIH GUDID Devices

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