Biomet微型固定OmniMax MMF系统
K号: K202969 · 2021-08-05
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决定日期2021-08-05
产品代码JEY
咨询委员会DE
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决定实质等同
器械摘要
Biomet Microfixation OmniMax MMF System is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Microfixation. It received FDA 510(k) clearance on 2021-08-05 under 510(k) number K202969. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Biomet Microfixation OmniMax MMF System?
Biomet Microfixation OmniMax MMF System is a medical device that received FDA 510(k) clearance on 2021-08-05. The listed applicant is Biomet Microfixation. The 510(k) number is K202969.
When did Biomet Microfixation OmniMax MMF System receive FDA 510(k) clearance?
Biomet Microfixation OmniMax MMF System received FDA 510(k) clearance on 2021-08-05, under 510(k) number K202969.
Who is the listed applicant for Biomet Microfixation OmniMax MMF System?
The FDA 510(k) record lists Biomet Microfixation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Biomet Microfixation OmniMax MMF System?
The FDA product code for Biomet Microfixation OmniMax MMF System is JEY.
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Biomet Microfixation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：JEY）
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。
K260137KLS Martin IPS 口腔-Max 种植体 - MR 条件性；个体化患者解决方案 - Ti (IPS-Ti)；个体化患者解决方案 - PEEK (IPS-PEEK)；KLS Martin 个体化患者解决方案KLS-Martin L.P.K253206细致入微的个性化CMF解决方案Meticuly Co., Ltd.K252246Leforte MMF 系统Jeil Medical CorporationK253373Southern 颅面 (CMF) 系统Southern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby生物可吸收固定系统；Inion CPS 1.5/2.0/2.5生物可吸收固定系统Inion OYK241314KLS Martin 口腔-Max 嵌入物 MR 条件性（捆绑）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。
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