OsteoCentric 导航工具系统
K号: K250520 · 2025-10-27
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决定日期2025-10-27
产品代码OLO
咨询委员会NE
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器械摘要
OsteoCentric Navigated Instruments System is the device name listed in this FDA 510(k) record. The listed applicant is Osteocentric Technologies, Inc.. It received FDA 510(k) clearance on 2025-10-27 under 510(k) number K250520. 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 OsteoCentric Navigated Instruments System?
OsteoCentric Navigated Instruments System is a medical device that received FDA 510(k) clearance on 2025-10-27. The listed applicant is Osteocentric Technologies, Inc.. The 510(k) number is K250520.
When did OsteoCentric Navigated Instruments System receive FDA 510(k) clearance?
OsteoCentric Navigated Instruments System received FDA 510(k) clearance on 2025-10-27, under 510(k) number K250520.
Who is the listed applicant for OsteoCentric Navigated Instruments System?
The FDA 510(k) record lists Osteocentric Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OsteoCentric Navigated Instruments System?
The FDA product code for OsteoCentric Navigated Instruments 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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