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FDA 510(k)

BoneTrust Implant System

K-Number: K182313 · 2019-03-11

ApplicantMedical Instinct Deutschland GmbH
Decision Date2019-03-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BoneTrust Implant System is a medical device manufactured by Medical Instinct Deutschland GmbH. It received FDA 510(k) clearance on 2019-03-11 under approval number K182313. 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 Implant System?

BoneTrust Implant System is a medical device that received FDA 510(k) clearance on 2019-03-11. It is manufactured by Medical Instinct Deutschland GmbH. The 510(k) number is K182313.

When was BoneTrust Implant System approved by the FDA?

BoneTrust Implant System received FDA 510(k) clearance on 2019-03-11, under approval number K182313.

What company makes BoneTrust Implant System?

BoneTrust Implant System is manufactured by Medical Instinct Deutschland GmbH.

What is the FDA product code for BoneTrust Implant System?

The FDA product code for BoneTrust 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

K200573BoneTrust Mini 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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