Stryker可吸收固定系统
K号: K213777 · 2022-02-04
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决定日期2022-02-04
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
Stryker Resorbable Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger Micro Implants. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K213777. 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 Stryker Resorbable Fixation System?
Stryker Resorbable Fixation System is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Stryker Leibinger Micro Implants. The 510(k) number is K213777.
When did Stryker Resorbable Fixation System receive FDA 510(k) clearance?
Stryker Resorbable Fixation System received FDA 510(k) clearance on 2022-02-04, under 510(k) number K213777.
Who is the listed applicant for Stryker Resorbable Fixation System?
The FDA 510(k) record lists Stryker Leibinger Micro Implants as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Stryker Resorbable Fixation System?
The FDA product code for Stryker Resorbable Fixation 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。
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。
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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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