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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 the device name listed in this FDA 510(k) record. The listed applicant is Hager& Meisinger GmbH. It received FDA 510(k) clearance on 2018-08-09 under 510(k) 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. The listed applicant is Hager& Meisinger GmbH. The 510(k) number is K173819.

When did MyPlant II Implant System receive FDA 510(k) clearance?

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

Who is the listed applicant for MyPlant II Implant System?

The FDA 510(k) record lists Hager& Meisinger GmbH as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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