True Tulip, True M.I.S.

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, True M.i.s..

Pre-market Notification Details

Device IDK220297
510k NumberK220297
Device Name:True Tulip, True M.I.S.
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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-02
Decision Date2022-09-16

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