Everest Spinal System

Thoracolumbosacral Pedicle Screw System

K2M, Inc

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

Pre-market Notification Details

Device IDK151216
510k NumberK151216
Device Name:Everest Spinal System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant K2M, Inc 751 Miller Drive SE Leesburg,  VA  20175
ContactNancy Giezen
CorrespondentNancy Giezen
K2M, Inc 751 Miller Drive SE Leesburg,  VA  20175
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeOSH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-05-06
Decision Date2015-08-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10888857158245 K151216 000
10888857158238 K151216 000
10888857158221 K151216 000
10888857271395 K151216 000

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