CASCADIA Interbody System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

K2M

The following data is part of a premarket notification filed by K2m with the FDA for Cascadia Interbody System.

Pre-market Notification Details

Device IDK172941
510k NumberK172941
Device Name:CASCADIA Interbody System
ClassificationIntervertebral Fusion Device With Integrated Fixation, Lumbar
Applicant K2M 600 Hope Parkway SE Leesburg,  VA  20175
ContactNancy Giezen
CorrespondentNancy Giezen
K2M 600 Hope Parkway SE Leesburg,  VA  20175
Product CodeOVD  
Subsequent Product CodeMAX
Subsequent Product CodeODP
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-26
Decision Date2018-02-12
Summary:summary

NIH GUDID Devices

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