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FDA 510(k)

H-Max S stem

K号: K160011 · 2016-08-22

申请人Lima Corporate S.P.A.
决定日期2016-08-22
产品代码MEH
咨询委员会OR
决定Substantially Equivalent

器械摘要

H-Max S stem is the device name listed in this FDA 510(k) record. The listed applicant is Lima Corporate S.P.A.. It received FDA 510(k) clearance on 2016-08-22 under 510(k) number K160011. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the H-Max S stem?

H-Max S stem is a medical device that received FDA 510(k) clearance on 2016-08-22. The listed applicant is Lima Corporate S.P.A.. The 510(k) number is K160011.

When did H-Max S stem receive FDA 510(k) clearance?

H-Max S stem received FDA 510(k) clearance on 2016-08-22, under 510(k) number K160011.

Who is the listed applicant for H-Max S stem?

The FDA 510(k) record lists Lima Corporate S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for H-Max S stem?

The FDA product code for H-Max S stem is MEH.

列明Lima Corporate S.P.A.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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相关器械（代码：MEH）

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。

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, Inc.

官方来源

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