K2M Growing Spine System

Growing Rod System

K2M, Inc.

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

Pre-market Notification Details

Device IDK161028
510k NumberK161028
Device Name:K2M Growing Spine System
ClassificationGrowing Rod System
Applicant K2M, Inc. 751 Miller Drive SE Leesburg,  VA  20175
ContactNancy Giezen
CorrespondentNancy Giezen
K2M, Inc. 600 Hope Parkway Southeast Leesburg,  VA  20175
Product CodePGM  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-04-12
Decision Date2016-07-22
Summary:summary

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