mBôs（Monogram mBôs TKA系统）
K号: K242121 · 2025-03-14
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决定日期2025-03-14
产品代码OLO
咨询委员会NE
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决定实质等同
器械摘要
mBôs (Monogram mBôs TKA System) is the device name listed in this FDA 510(k) record. The listed applicant is Monogram Orthopaedics, Inc.. It received FDA 510(k) clearance on 2025-03-14 under 510(k) number K242121. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the mBôs (Monogram mBôs TKA System)?
mBôs (Monogram mBôs TKA System) is a medical device that received FDA 510(k) clearance on 2025-03-14. The listed applicant is Monogram Orthopaedics, Inc.. The 510(k) number is K242121.
When did mBôs (Monogram mBôs TKA System) receive FDA 510(k) clearance?
mBôs (Monogram mBôs TKA System) received FDA 510(k) clearance on 2025-03-14, under 510(k) number K242121.
Who is the listed applicant for mBôs (Monogram mBôs TKA System)?
The FDA 510(k) record lists Monogram Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for mBôs (Monogram mBôs TKA System)?
The FDA product code for mBôs (Monogram mBôs TKA System) is OLO.
相关临床试验
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相关器械（代码：OLO）
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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