K2M Expandable Interbody System

Intervertebral Fusion Device With Bone Graft, Lumbar

K2M, Inc.

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

Pre-market Notification Details

Device IDK180777
510k NumberK180777
Device Name:K2M Expandable Interbody System
ClassificationIntervertebral Fusion Device With Bone Graft, Lumbar
Applicant K2M, Inc. 600 Hope Parkway SE Leesburg,  VA  20175
ContactNancy Giezen
CorrespondentNancy Giezen
K2M 600 Hope Parkway SE Leesburg,  VA  20175
Product CodeMAX  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-26
Decision Date2018-08-03
Summary:summary

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