OssBuilder 系统
K号: K181854 · 2019-05-07
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决定日期2019-05-07
产品代码DZL
咨询委员会DE
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决定实质等同
器械摘要
OssBuilder System 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 2019-05-07 under 510(k) number K181854. 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 OssBuilder System?
OssBuilder System is a medical device that received FDA 510(k) clearance on 2019-05-07. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K181854.
When did OssBuilder System receive FDA 510(k) clearance?
OssBuilder System received FDA 510(k) clearance on 2019-05-07, under 510(k) number K181854.
Who is the listed applicant for OssBuilder System?
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 OssBuilder System?
The FDA product code for OssBuilder System 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 GmbHK251569骨螺钉Osstem Implant Co., Ltd.K243190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 GmbH
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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