MOJAVE 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 Mojave Expandable Interbody System.

Pre-market Notification Details

Device IDK171097
510k NumberK171097
Device Name:MOJAVE 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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-04-13
Decision Date2017-05-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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