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FDA 510(k)

AnyOne External Implant System

K-Number: K203554 · 2021-08-28

ApplicantMegagen Implant Co., Ltd.
Decision Date2021-08-28
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AnyOne External Implant System is a medical device manufactured by Megagen Implant Co., Ltd.. It received FDA 510(k) clearance on 2021-08-28 under approval number K203554. 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 AnyOne External Implant System?

AnyOne External Implant System is a medical device that received FDA 510(k) clearance on 2021-08-28. It is manufactured by Megagen Implant Co., Ltd.. The 510(k) number is K203554.

When was AnyOne External Implant System approved by the FDA?

AnyOne External Implant System received FDA 510(k) clearance on 2021-08-28, under approval number K203554.

What company makes AnyOne External Implant System?

AnyOne External Implant System is manufactured by Megagen Implant Co., Ltd..

What is the FDA product code for AnyOne External Implant System?

The FDA product code for AnyOne External 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 Megagen Implant Co., Ltd.

K192347ST Internal Implant System K182448AnyRidge Octa 1 Implant System K191127Advanced Intermezzo Implant System K190096R2GATE K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment K203808Multi-unit Abutment, Multi-unit Angled Abutment

View all 22 devices →

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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