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FDA 510(k)

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

K-Number: K201780 · 2020-07-22

ApplicantInnovative Surgical Designs, Inc.
Decision Date2020-07-22
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

True Tulip System, True M.I.S. System is a medical device manufactured by Innovative Surgical Designs, Inc.. It received FDA 510(k) clearance on 2020-07-22 under approval number K201780. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the True Tulip System, True M.I.S. System?

True Tulip System, True M.I.S. System is a medical device that received FDA 510(k) clearance on 2020-07-22. It is manufactured by Innovative Surgical Designs, Inc.. The 510(k) number is K201780.

When was True Tulip System, True M.I.S. System approved by the FDA?

True Tulip System, True M.I.S. System received FDA 510(k) clearance on 2020-07-22, under approval number K201780.

What company makes True Tulip System, True M.I.S. System?

True Tulip System, True M.I.S. System is manufactured by Innovative Surgical Designs, Inc..

What is the FDA product code for True Tulip System, True M.I.S. System?

The FDA product code for True Tulip System, True M.I.S. System is NKB.

Other Devices by Innovative Surgical Designs, Inc.

K171559True Spinal Fixation System K170710True Spinal Fixation System K181584Redi-Spine K210816True Tulip, True M.I.S. K220297True Tulip, True M.I.S. K212627True Tulip, True M.I.S.

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K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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