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FDA 510(k)

8plant Implant System

K-Number: K231426 · 2024-05-24

ApplicantHoowon Edi Co., Ltd.
Decision Date2024-05-24
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

8plant Implant System is a medical device manufactured by Hoowon Edi Co., Ltd.. It received FDA 510(k) clearance on 2024-05-24 under approval number K231426. 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 8plant Implant System?

8plant Implant System is a medical device that received FDA 510(k) clearance on 2024-05-24. It is manufactured by Hoowon Edi Co., Ltd.. The 510(k) number is K231426.

When was 8plant Implant System approved by the FDA?

8plant Implant System received FDA 510(k) clearance on 2024-05-24, under approval number K231426.

What company makes 8plant Implant System?

8plant Implant System is manufactured by Hoowon Edi Co., Ltd..

What is the FDA product code for 8plant Implant System?

The FDA product code for 8plant Implant System is DZE.

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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)

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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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