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FDA 510(k)

Origin Coxa Vara Hip Stem

K号: K161155 · 2016-07-19

申请人Signature Orthopaedics Pty, Ltd.
决定日期2016-07-19
产品代码MEH
咨询委员会OR
决定Substantially Equivalent

器械摘要

Origin Coxa Vara Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2016-07-19 under 510(k) number K161155. 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 Origin Coxa Vara Hip Stem?

Origin Coxa Vara Hip Stem is a medical device that received FDA 510(k) clearance on 2016-07-19. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K161155.

When did Origin Coxa Vara Hip Stem receive FDA 510(k) clearance?

Origin Coxa Vara Hip Stem received FDA 510(k) clearance on 2016-07-19, under 510(k) number K161155.

Who is the listed applicant for Origin Coxa Vara Hip Stem?

The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Origin Coxa Vara Hip Stem?

The FDA product code for Origin Coxa Vara Hip Stem is MEH.

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列明Signature Orthopaedics Pty, Ltd.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。

K252824Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadK253239Active-V Total Knee System; World Total Knee SystemK251771Cambridge Partial KneeK243021Longboard Revision Hip StemK242674Freedom Posterior Cervical ScrewsK242477Shoulder Soft Tissue Anchors

查看所有 42 个设备 →

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

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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