VU C*POD INTERVERTEBRAL BODY FUSION DEVICE

Intervertebral Fusion Device With Bone Graft, Cervical

THEKEN SPINE LLC

The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Vu C*pod Intervertebral Body Fusion Device.

Pre-market Notification Details

Device IDK111675
510k NumberK111675
Device Name:VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant THEKEN SPINE LLC 1153 MEDINA RD. Medina,  OH  44256 -0000
ContactDale Davison
CorrespondentDale Davison
THEKEN SPINE LLC 1153 MEDINA RD. Medina,  OH  44256 -0000
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-15
Decision Date2011-08-02
Summary:summary

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