RANGE SPINAL SYSTEM

Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

K2M, INC.

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

Pre-market Notification Details

Device IDK131030
510k NumberK131030
Device Name:RANGE SPINAL SYSTEM
ClassificationPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Applicant K2M, INC. 751 MILLER DR., S.E., SUITE F1 Leesburg,  VA  20175
ContactNancy Giezen
CorrespondentNancy Giezen
K2M, INC. 751 MILLER DR., S.E., SUITE F1 Leesburg,  VA  20175
Product CodeOSH  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-12
Decision Date2013-05-09
Summary:summary

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