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FDA 510(k)

ICX-Implant System

K-Number: K231566 · 2024-09-05

ApplicantMedentis Medical GmbH
Decision Date2024-09-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ICX-Implant System is a medical device manufactured by Medentis Medical GmbH. It received FDA 510(k) clearance on 2024-09-05 under approval number K231566. 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 ICX-Implant System?

ICX-Implant System is a medical device that received FDA 510(k) clearance on 2024-09-05. It is manufactured by Medentis Medical GmbH. The 510(k) number is K231566.

When was ICX-Implant System approved by the FDA?

ICX-Implant System received FDA 510(k) clearance on 2024-09-05, under approval number K231566.

What company makes ICX-Implant System?

ICX-Implant System is manufactured by Medentis Medical GmbH.

What is the FDA product code for ICX-Implant System?

The FDA product code for ICX-Implant System is DZE.

Related Clinical Trials

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Related PubMed Literature

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)

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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