Zavation Z-Link Lumbar

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Zavation, LLC

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

Pre-market Notification Details

Device IDK142271
510k NumberK142271
Device Name:Zavation Z-Link Lumbar
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant Zavation, LLC 400 Liberty Park Flowood,  MS  39232
ContactLawrence Walker
CorrespondentLawrence Walker
Zavation, LLC 400 Liberty Park Flowood,  MS  39232
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-15
Decision Date2014-12-19
Summary:summary

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