K2M Patient Specific Rods

Thoracolumbosacral Pedicle Screw System

K2M, Inc.

The following data is part of a premarket notification filed by K2m, Inc. with the FDA for K2m Patient Specific Rods.

Pre-market Notification Details

Device IDK180376
510k NumberK180376
Device Name:K2M Patient Specific Rods
ClassificationThoracolumbosacral Pedicle Screw System
Applicant K2M, Inc. 600 Hope Parkway SE Leesburg,  VA  20175
ContactNancy Giezen
CorrespondentNancy Giezen
K2M, Inc. 600 Hope Parkway Southeast Leesburg,  VA  20175
Product CodeNKB  
Subsequent Product CodeKWP
Subsequent Product CodeKWQ
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-02-12
Decision Date2018-04-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888857413054 K180376 000
10888857413047 K180376 000
10888857413030 K180376 000
10888857413023 K180376 000
10888857548701 K180376 000
10888857548695 K180376 000

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