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FDA 510(k)

MINICONE Implant

K-Number: K200906 · 2020-10-16

ApplicantMedentika GmbH
Decision Date2020-10-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MINICONE Implant is the device name listed in this FDA 510(k) record. The listed applicant is Medentika GmbH. It received FDA 510(k) clearance on 2020-10-16 under 510(k) number K200906. 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 MINICONE Implant?

MINICONE Implant is a medical device that received FDA 510(k) clearance on 2020-10-16. The listed applicant is Medentika GmbH. The 510(k) number is K200906.

When did MINICONE Implant receive FDA 510(k) clearance?

MINICONE Implant received FDA 510(k) clearance on 2020-10-16, under 510(k) number K200906.

Who is the listed applicant for MINICONE Implant?

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

What is the FDA product code for MINICONE Implant?

The FDA product code for MINICONE Implant is DZE.

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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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