Adaptix Interbody System With Titan NanoLOCK Surface Technology

Intervertebral Fusion Device With Bone Graft, Lumbar

Medtronic Sofamor Danek

The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Adaptix Interbody System With Titan Nanolock Surface Technology.

Pre-market Notification Details

Device IDK201267
510k NumberK201267
Device Name:Adaptix Interbody System With Titan NanoLOCK Surface Technology
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant Medtronic Sofamor Danek 1800 Pyramid Place Memphis,  TN  38132
ContactDiamond Wallace
CorrespondentDiamond Wallace
Medtronic Sofamor Danek 1800 Pyramid Place Memphis,  TN  38132
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-12
Decision Date2020-08-26

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.