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FDA 510(k)

MyPlant II Implant System

K-Number: K173819 · 2018-08-09

ApplicantHager& Meisinger GmbH
Decision Date2018-08-09
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MyPlant II Implant System is a medical device manufactured by Hager& Meisinger GmbH. It received FDA 510(k) clearance on 2018-08-09 under approval number K173819. 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 MyPlant II Implant System?

MyPlant II Implant System is a medical device that received FDA 510(k) clearance on 2018-08-09. It is manufactured by Hager& Meisinger GmbH. The 510(k) number is K173819.

When was MyPlant II Implant System approved by the FDA?

MyPlant II Implant System received FDA 510(k) clearance on 2018-08-09, under approval number K173819.

What company makes MyPlant II Implant System?

MyPlant II Implant System is manufactured by Hager& Meisinger GmbH.

What is the FDA product code for MyPlant II Implant System?

The FDA product code for MyPlant II 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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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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