Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody Sys

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 Endoskeleton Tc Interbody System, Endoskeleton Tcs Interbody System, Endoskeleton Ta Interbody System, Endoskeleton Tas & Tas Hyp Interbody System, Endoskeleton Tl Interbody System, Endoskeleton Tl Hyp. Interbody System, Endoskeleton To Interbody Sys.

Pre-market Notification Details

Device IDK211258
510k NumberK211258
Device Name:Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody Sys
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis,  TN  38132
ContactKelly Mcdonnell
CorrespondentKelly Mcdonnell
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis,  TN  38132
Product CodeMAX  
Subsequent Product CodeODP
Subsequent Product CodeOVD
Subsequent Product CodeOVE
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-26
Decision Date2021-05-26

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