SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

SPINEFRONTIER, INC.

The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Spinefrontier Pedfuse Pedicle Screw System.

Pre-market Notification Details

Device IDK133153
510k NumberK133153
Device Name:SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant SPINEFRONTIER, INC. 500 CUMMINGS CENTER SUITE 3500 Beverly,  MA  01915
ContactPaul L Speidel
CorrespondentPaul L Speidel
SPINEFRONTIER, INC. 500 CUMMINGS CENTER SUITE 3500 Beverly,  MA  01915
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-17
Decision Date2014-05-14
Summary:summary

NIH GUDID Devices

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