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FDA 510(k)

Osstem Implant System

K-Number: K222778 · 2023-09-23

ApplicantOsstem Implant Co., Ltd.
Decision Date2023-09-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Osstem Implant System is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2023-09-23 under approval number K222778. 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 Osstem Implant System?

Osstem Implant System is a medical device that received FDA 510(k) clearance on 2023-09-23. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K222778.

When was Osstem Implant System approved by the FDA?

Osstem Implant System received FDA 510(k) clearance on 2023-09-23, under approval number K222778.

What company makes Osstem Implant System?

Osstem Implant System is manufactured by Osstem Implant Co., Ltd..

What is the FDA product code for Osstem Implant System?

The FDA product code for Osstem 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 Osstem Implant Co., Ltd.

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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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