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FDA 510(k)

BoneTrust Mini Implant System

K-Number: K200573 · 2021-05-14

ApplicantMedical Instinct Deutschland GmbH
Decision Date2021-05-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BoneTrust Mini Implant System is a medical device manufactured by Medical Instinct Deutschland GmbH. It received FDA 510(k) clearance on 2021-05-14 under approval number K200573. 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 BoneTrust Mini Implant System?

BoneTrust Mini Implant System is a medical device that received FDA 510(k) clearance on 2021-05-14. It is manufactured by Medical Instinct Deutschland GmbH. The 510(k) number is K200573.

When was BoneTrust Mini Implant System approved by the FDA?

BoneTrust Mini Implant System received FDA 510(k) clearance on 2021-05-14, under approval number K200573.

What company makes BoneTrust Mini Implant System?

BoneTrust Mini Implant System is manufactured by Medical Instinct Deutschland GmbH.

What is the FDA product code for BoneTrust Mini Implant System?

The FDA product code for BoneTrust Mini 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)

Other Devices by Medical Instinct Deutschland GmbH

K182313BoneTrust Implant System

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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