植入器及附件
K号: K211358 · 2022-11-21
广告
决定日期2022-11-21
产品代码EBW
咨询委员会DE
请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
决定实质等同
器械摘要
Implanter incl. Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K211358. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Implanter incl. Accessories?
Implanter incl. Accessories is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Guilin Woodpecker Medical Instrument Co., Ltd.. The 510(k) number is K211358.
When did Implanter incl. Accessories receive FDA 510(k) clearance?
Implanter incl. Accessories received FDA 510(k) clearance on 2022-11-21, under 510(k) number K211358.
Who is the listed applicant for Implanter incl. Accessories?
The FDA 510(k) record lists Guilin Woodpecker Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Implanter incl. Accessories?
The FDA product code for Implanter incl. Accessories is EBW.
相关临床试验
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。
列明Guilin Woodpecker Medical Instrument Co., Ltd.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：EBW）
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。
K251407通过塑性诱导皮质刺激进行运动恢复试验Saeshin Precision Co., Ltd.K251701Star E900 电系统Dentalez, Inc., Stardental DivisionK251811运动和顶点模块（MaAM）Dentsply Sirona, Inc.K231562ELEC 发动机（型号：ISE-170L）Micro-Nx Co., Ltd.K242646牙科植入单元Guilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, Inc.
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。
广告