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FDA 510(k)

Highness Implant System

K-Number: K240383 · 2024-10-31

ApplicantHighness Co., Ltd.
Decision Date2024-10-31
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Highness Implant System is a medical device manufactured by Highness Co., Ltd.. It received FDA 510(k) clearance on 2024-10-31 under approval number K240383. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Highness Implant System?

Highness Implant System is a medical device that received FDA 510(k) clearance on 2024-10-31. It is manufactured by Highness Co., Ltd.. The 510(k) number is K240383.

When was Highness Implant System approved by the FDA?

Highness Implant System received FDA 510(k) clearance on 2024-10-31, under approval number K240383.

What company makes Highness Implant System?

Highness Implant System is manufactured by Highness Co., Ltd..

What is the FDA product code for Highness Implant System?

The FDA product code for Highness Implant System is DZE.

Related Clinical Trials

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Related Devices (Code: DZE)

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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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