TRUE SPINAL FUSSION SYSTEM

Orthosis, Spondylolisthesis Spinal Fixation

INNOVATIVE SURGICAL DESIGNS

The following data is part of a premarket notification filed by Innovative Surgical Designs with the FDA for True Spinal Fussion System.

Pre-market Notification Details

Device IDK133690
510k NumberK133690
Device Name:TRUE SPINAL FUSSION SYSTEM
ClassificationOrthosis, Spondylolisthesis Spinal Fixation
Applicant INNOVATIVE SURGICAL DESIGNS 2660 E. 2ND STREET #10 Bloomington,  IN  47401
ContactEd Morris
CorrespondentEd Morris
INNOVATIVE SURGICAL DESIGNS 2660 E. 2ND STREET #10 Bloomington,  IN  47401
Product CodeMNH  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-12-02
Decision Date2014-05-07
Summary:summary

NIH GUDID Devices

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