VU APOD INTERVERTABRAL BODY FUSION DEVICE

Intervertebral Fusion Device With Integrated Fixation, Lumbar

THEKEN SPINE LLC

The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Vu Apod Intervertabral Body Fusion Device.

Pre-market Notification Details

Device IDK080822
510k NumberK080822
Device Name:VU APOD INTERVERTABRAL BODY FUSION DEVICE
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant THEKEN SPINE LLC 1800 TRIPLETT BLVD. Akron,  OH  44306
ContactDale Davison
CorrespondentDale Davison
THEKEN SPINE LLC 1800 TRIPLETT BLVD. Akron,  OH  44306
Product CodeOVD  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-03-24
Decision Date2008-07-02
Summary:summary

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