OSSIX BONE
K号: K163714 · 2017-07-18
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决定日期2017-07-18
产品代码NPM
咨询委员会DE
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器械摘要
OSSIX BONE is the device name listed in this FDA 510(k) record. The listed applicant is Datum Dental, Ltd.. It received FDA 510(k) clearance on 2017-07-18 under 510(k) number K163714. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OSSIX BONE?
OSSIX BONE is a medical device that received FDA 510(k) clearance on 2017-07-18. The listed applicant is Datum Dental, Ltd.. The 510(k) number is K163714.
When did OSSIX BONE receive FDA 510(k) clearance?
OSSIX BONE received FDA 510(k) clearance on 2017-07-18, under 510(k) number K163714.
Who is the listed applicant for OSSIX BONE?
The FDA 510(k) record lists Datum Dental, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OSSIX BONE?
The FDA product code for OSSIX BONE is NPM.
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Datum Dental, 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：NPM）
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。
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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