CONDUIT Lateral Switch Plate

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 Conduit Lateral Switch Plate.

Pre-market Notification Details

Device IDK221325
510k NumberK221325
Device Name:CONDUIT Lateral Switch Plate
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Medos International, SARL Chemin-Blanc 38 Le Locle,  CH 2400
ContactLiJuan He
CorrespondentLiJuan He
DePuy Spine 325 Paramount Dr. Raynham,  MA  02767
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-06
Decision Date2022-08-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10705034574684 K221325 000
10705034574523 K221325 000

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