FDA 510(k)

MEDPOR 定制植入套件

K号: K254233 · 2026-03-12

决定日期2026-03-12

产品代码FWP

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决定实质等同

器械摘要

MEDPOR Customized Implant Kit is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K254233. The device is classified under product code FWP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MEDPOR Customized Implant Kit?

MEDPOR Customized Implant Kit is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K254233.

When did MEDPOR Customized Implant Kit receive FDA 510(k) clearance?

MEDPOR Customized Implant Kit received FDA 510(k) clearance on 2026-03-12, under 510(k) number K254233.

Who is the listed applicant for MEDPOR Customized Implant Kit?

The FDA 510(k) record lists Stryker Leibinger GmbH & Co KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDPOR Customized Implant Kit?

The FDA product code for MEDPOR Customized Implant Kit is FWP.

列明Stryker Leibinger GmbH & Co KG为申报人的其他记录

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

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