RANGE 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 Range Spinal System.

Pre-market Notification Details

Device IDK141147
510k NumberK141147
Device Name:RANGE SPINAL SYSTEM
ClassificationThoracolumbosacral Pedicle Screw System
Applicant K2M, INC. 751 MILLER DR.,SE Leesburg,  VA  20175
ContactNancy Giezen
CorrespondentNancy Giezen
K2M, INC. 751 MILLER DR.,SE Leesburg,  VA  20175
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeMNH
Subsequent Product CodeMNI
Subsequent Product CodeOSH
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-05-05
Decision Date2014-06-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888857112605 K141147 000
10888857112360 K141147 000
10888857112438 K141147 000
10888857112469 K141147 000
10888857112544 K141147 000
10888857112551 K141147 000
10888857112568 K141147 000
10888857112575 K141147 000
10888857112582 K141147 000
10888857112599 K141147 000
10888857112339 K141147 000

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