骨螺钉
K号: K251569 · 2025-08-13
广告
决定日期2025-08-13
产品代码DZL
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
Bone Screw is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2025-08-13 under 510(k) number K251569. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Bone Screw?
Bone Screw is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K251569.
When did Bone Screw receive FDA 510(k) clearance?
Bone Screw received FDA 510(k) clearance on 2025-08-13, under 510(k) number K251569.
Who is the listed applicant for Bone Screw?
The FDA 510(k) record lists Osstem Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Bone Screw?
The FDA product code for Bone Screw is DZL.
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Osstem Implant 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：DZL）
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。
K254286引导性骨再生系统DentalMaster(Xiamen)Medical Technology Co., Ltd.K250123Master-Pin X（带螺纹的MP Pin）（36BMP000030 / MP30）Hager& Meisinger GmbHK243190定制骨固定/骨增强系统 - PINUstomed Instrumente Ulrich Storz GmbH & Co. KGK233419GBR系统Proimtech Saglik Urunleri Anonim SirketiK240321MP 平面无螺纹销 (36BMP000020/MP20)Hager& Meisinger GmbHK233721KLS Martin 无钻 MMF 螺丝KLS-Martin L.P.
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