MT-Bone
K号: K242432 · 2024-08-19
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决定日期2024-08-19
产品代码DZI
咨询委员会DE
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决定实质等同
器械摘要
MT-Bone is the device name listed in this FDA 510(k) record. The listed applicant is Mectron S.P.A.. It received FDA 510(k) clearance on 2024-08-19 under 510(k) number K242432. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the MT-Bone?
MT-Bone is a medical device that received FDA 510(k) clearance on 2024-08-19. The listed applicant is Mectron S.P.A.. The 510(k) number is K242432.
When did MT-Bone receive FDA 510(k) clearance?
MT-Bone received FDA 510(k) clearance on 2024-08-19, under 510(k) number K242432.
Who is the listed applicant for MT-Bone?
The FDA 510(k) record lists Mectron S.P.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MT-Bone?
The FDA product code for MT-Bone is DZI.
列明Mectron S.P.A.为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：DZI）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K253655斜角螺丝刀 MED（M-SD090）W&H Dentalwerk Bürmoos GmbHK253776Implantmed Plus II & Piezomed Plus II 模块W&H Dentalwerk Buermoos GmbHK254163VarioSurg 4Nakanishi, Inc.K240340Surgical Drive System (型号：ES70，ES90，E8)Guangdong Jinme Medical Technology Co., Ltd.K231087引导手术套件Implant Direct Sybron Manufacturing, LLCK192561TRAUS SUS20Saeshin Precision Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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