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FDA 510(k)

True Spinal Fixation System

K-Number: K171559 · 2017-07-24

ApplicantInnovative Surgical Designs, Inc.
Decision Date2017-07-24
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

True Spinal Fixation System is a medical device manufactured by Innovative Surgical Designs, Inc.. It received FDA 510(k) clearance on 2017-07-24 under approval number K171559. 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 Spinal Fixation System?

True Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2017-07-24. It is manufactured by Innovative Surgical Designs, Inc.. The 510(k) number is K171559.

When was True Spinal Fixation System approved by the FDA?

True Spinal Fixation System received FDA 510(k) clearance on 2017-07-24, under approval number K171559.

What company makes True Spinal Fixation System?

True Spinal Fixation System is manufactured by Innovative Surgical Designs, Inc..

What is the FDA product code for True Spinal Fixation System?

The FDA product code for True Spinal Fixation System is NKB.

Related Clinical Trials

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Innovative Surgical Designs, Inc.

K170710True Spinal Fixation System K181584Redi-Spine K201780True Tulip System, True M.I.S. System K210816True Tulip, True M.I.S. K220297True Tulip, True M.I.S. K212627True Tulip, True M.I.S.

View all 7 devices →

Related Devices (Code: NKB)

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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