BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL

Intervertebral Fusion Device With Bone Graft, Lumbar

MEDOS INTERNATIONAL, SARL

The following data is part of a premarket notification filed by Medos International, Sarl with the FDA for Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar, Cougar System, Cougar Ls Lateral.

Pre-market Notification Details

Device IDK140759
510k NumberK140759
Device Name:BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant MEDOS INTERNATIONAL, SARL 325 Paramount Drive Raynham,  MA  02767
ContactLinda Bernier
CorrespondentLinda Bernier
MEDOS INTERNATIONAL, SARL 325 Paramount Drive Raynham,  MA  02767
Product CodeMAX  
Subsequent Product CodeMQP
Subsequent Product CodeODP
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-26
Decision Date2014-06-13
Summary:summary

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