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FDA 510(k)

IH Implant System

K-Number: K153521 · 2016-10-14

ApplicantSewonmedix, Inc.
Decision Date2016-10-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IH Implant System is a medical device manufactured by Sewonmedix, Inc.. It received FDA 510(k) clearance on 2016-10-14 under approval number K153521. 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 IH Implant System?

IH Implant System is a medical device that received FDA 510(k) clearance on 2016-10-14. It is manufactured by Sewonmedix, Inc.. The 510(k) number is K153521.

When was IH Implant System approved by the FDA?

IH Implant System received FDA 510(k) clearance on 2016-10-14, under approval number K153521.

What company makes IH Implant System?

IH Implant System is manufactured by Sewonmedix, Inc..

What is the FDA product code for IH Implant System?

The FDA product code for IH Implant System is DZE.

Related Clinical Trials

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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 Sewonmedix, Inc.

K222707IH 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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