ZENEX Implant System_Narrow
K-Number: K230630 · 2023-07-31
ApplicantIzenimplant Co., Ltd.
Decision Date2023-07-31
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ZENEX Implant System_Narrow is a medical device manufactured by Izenimplant Co., Ltd.. It received FDA 510(k) clearance on 2023-07-31 under approval number K230630. 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 ZENEX Implant System_Narrow?
ZENEX Implant System_Narrow is a medical device that received FDA 510(k) clearance on 2023-07-31. It is manufactured by Izenimplant Co., Ltd.. The 510(k) number is K230630.
When was ZENEX Implant System_Narrow approved by the FDA?
ZENEX Implant System_Narrow received FDA 510(k) clearance on 2023-07-31, under approval number K230630.
What company makes ZENEX Implant System_Narrow?
ZENEX Implant System_Narrow is manufactured by Izenimplant Co., Ltd..
What is the FDA product code for ZENEX Implant System_Narrow?
The FDA product code for ZENEX Implant System_Narrow is DZE.
Other Devices by Izenimplant Co., Ltd.
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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.