True Tulip System, True M.I.S. System

Thoracolumbosacral Pedicle Screw System

Innovative Surgical Designs, Inc.

The following data is part of a premarket notification filed by Innovative Surgical Designs, Inc. with the FDA for True Tulip System, True M.i.s. System.

Pre-market Notification Details

Device IDK201780
510k NumberK201780
Device Name:True Tulip System, True M.I.S. System
ClassificationThoracolumbosacral Pedicle Screw System
Applicant Innovative Surgical Designs, Inc. 3903 S. Walnut St. Bloomington,  IN  47401
ContactJon Rinehart
CorrespondentJon Rinehart
Innovative Surgical Designs, Inc. 3903 S. Walnut St. Bloomington,  IN  47401
Product CodeNKB  
CFR Regulation Number888.3070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-30
Decision Date2020-07-22

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.