Ortholock 锚定装置
K号: K202691 · 2022-04-28
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决定日期2022-04-28
产品代码OAT
咨询委员会DE
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决定实质等同
器械摘要
Ortholock Anchorage Devices is the device name listed in this FDA 510(k) record. The listed applicant is Craniofacial Technologies, Inc.. It received FDA 510(k) clearance on 2022-04-28 under 510(k) number K202691. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Ortholock Anchorage Devices?
Ortholock Anchorage Devices is a medical device that received FDA 510(k) clearance on 2022-04-28. The listed applicant is Craniofacial Technologies, Inc.. The 510(k) number is K202691.
When did Ortholock Anchorage Devices receive FDA 510(k) clearance?
Ortholock Anchorage Devices received FDA 510(k) clearance on 2022-04-28, under 510(k) number K202691.
Who is the listed applicant for Ortholock Anchorage Devices?
The FDA 510(k) record lists Craniofacial Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ortholock Anchorage Devices?
The FDA product code for Ortholock Anchorage Devices is OAT.
相关临床试验
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相关器械（代码：OAT）
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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