Intra-Lock骨固定系统
K号: K171831 · 2017-10-26
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决定日期2017-10-26
产品代码DZL
咨询委员会DE
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决定实质等同
器械摘要
Intra-Lock Bone Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Intra-Lock International, Inc.. It received FDA 510(k) clearance on 2017-10-26 under 510(k) number K171831. The device is classified under product code DZL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Intra-Lock Bone Fixation System?
Intra-Lock Bone Fixation System is a medical device that received FDA 510(k) clearance on 2017-10-26. The listed applicant is Intra-Lock International, Inc.. The 510(k) number is K171831.
When did Intra-Lock Bone Fixation System receive FDA 510(k) clearance?
Intra-Lock Bone Fixation System received FDA 510(k) clearance on 2017-10-26, under 510(k) number K171831.
Who is the listed applicant for Intra-Lock Bone Fixation System?
The FDA 510(k) record lists Intra-Lock International, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Intra-Lock Bone Fixation System?
The FDA product code for Intra-Lock Bone Fixation System is DZL.
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。
相关器械（代码：DZL）
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。
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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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