Fortilink Cages With TiPlus Technology

Intervertebral Fusion Device With Bone Graft, Lumbar

Paradigm Spine, GmbH

The following data is part of a premarket notification filed by Paradigm Spine, Gmbh with the FDA for Fortilink Cages With Tiplus Technology.

Pre-market Notification Details

Device IDK201453
510k NumberK201453
Device Name:Fortilink Cages With TiPlus Technology
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Paradigm Spine, GmbH 505 Park Avenue, 14th Floor New York,  NY  10022
ContactAlberto Jurado
CorrespondentJustin Eggleton
MCRA, LLC 1050 K Street NW, Suite 1000 Washington,  DC  20001
Product CodeMAX  
Subsequent Product CodeODP
Subsequent Product CodeOVD
Subsequent Product CodeOVE
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-01
Decision Date2020-10-07

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