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FDA 510(k)

IRENE Thoracolumbar Fixation System

K-Number: K172267 · 2018-03-06

ApplicantTianjin Zhengtian Medical Instrument Co., Ltd.
Decision Date2018-03-06
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IRENE Thoracolumbar Fixation System is a medical device manufactured by Tianjin Zhengtian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2018-03-06 under approval number K172267. 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 IRENE Thoracolumbar Fixation System?

IRENE Thoracolumbar Fixation System is a medical device that received FDA 510(k) clearance on 2018-03-06. It is manufactured by Tianjin Zhengtian Medical Instrument Co., Ltd.. The 510(k) number is K172267.

When was IRENE Thoracolumbar Fixation System approved by the FDA?

IRENE Thoracolumbar Fixation System received FDA 510(k) clearance on 2018-03-06, under approval number K172267.

What company makes IRENE Thoracolumbar Fixation System?

IRENE Thoracolumbar Fixation System is manufactured by Tianjin Zhengtian Medical Instrument Co., Ltd..

What is the FDA product code for IRENE Thoracolumbar Fixation System?

The FDA product code for IRENE Thoracolumbar Fixation System is NKB.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT07079774 TrueLok Elevate PMCF Study RECRUITING

Other Devices by Tianjin Zhengtian Medical Instrument Co., Ltd.

K151508IRENE Locking Compression Plate System K170056IRENE Cannulated Screw System

Related Devices (Code: NKB)

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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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