Catalyft LS Expandable Interbody System

Intervertebral Fusion Device With Bone Graft, Lumbar

Medtronic Sofamor Danek USA, Inc.

The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Catalyft Ls Expandable Interbody System.

Pre-market Notification Details

Device IDK212653
510k NumberK212653
Device Name:Catalyft LS Expandable Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis,  TN  38132
ContactMadhuvanthi Soundirarajan
CorrespondentMadhuvanthi Soundirarajan
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis,  TN  38132
Product CodeMAX  
Subsequent Product CodeKWQ
Subsequent Product CodeOVD
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-23
Decision Date2021-11-19

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.