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FDA 510(k)

Internal Hex Implant System

K-Number: K190837 · 2020-01-22

ApplicantEbi, Inc.
Decision Date2020-01-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Internal Hex Implant System is a medical device manufactured by Ebi, Inc.. It received FDA 510(k) clearance on 2020-01-22 under approval number K190837. 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 Internal Hex Implant System?

Internal Hex Implant System is a medical device that received FDA 510(k) clearance on 2020-01-22. It is manufactured by Ebi, Inc.. The 510(k) number is K190837.

When was Internal Hex Implant System approved by the FDA?

Internal Hex Implant System received FDA 510(k) clearance on 2020-01-22, under approval number K190837.

What company makes Internal Hex Implant System?

Internal Hex Implant System is manufactured by Ebi, Inc..

What is the FDA product code for Internal Hex Implant System?

The FDA product code for Internal Hex 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 Ebi, Inc.

K170031Internal Octa 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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