NEX-D2 Posterior Fixation System

Thoracolumbosacral Pedicle Screw System

Next OrthoSurgical

The following data is part of a premarket notification filed by Next Orthosurgical with the FDA for Nex-d2 Posterior Fixation System.

Pre-market Notification Details

Device IDK190981
510k NumberK190981
Device Name:NEX-D2 Posterior Fixation System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Next OrthoSurgical 3270 Corporate View, Suite A Vista,  CA  92081
ContactSartaj Kaur-hurrle
CorrespondentSartaj Kaur-hurrle
Next OrthoSurgical 3270 Corporate View, Suite A Vista,  CA  92081
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-15
Decision Date2020-01-15

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