FDA 510(k)

MicroPort Orthopedics Total Hip Systems MR Labeling

Номер K: K173898 · 2018-09-20

ЗаявительMicroport Orthopedics Inc. (Mpo)

Дата решения2018-09-20

Код продуктаLZO

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

MicroPort Orthopedics Total Hip Systems MR Labeling is the device name listed in this FDA 510(k) record. The listed applicant is Microport Orthopedics Inc. (Mpo). It received FDA 510(k) clearance on 2018-09-20 under 510(k) number K173898. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the MicroPort Orthopedics Total Hip Systems MR Labeling?

MicroPort Orthopedics Total Hip Systems MR Labeling is a medical device that received FDA 510(k) clearance on 2018-09-20. The listed applicant is Microport Orthopedics Inc. (Mpo). The 510(k) number is K173898.

When did MicroPort Orthopedics Total Hip Systems MR Labeling receive FDA 510(k) clearance?

MicroPort Orthopedics Total Hip Systems MR Labeling received FDA 510(k) clearance on 2018-09-20, under 510(k) number K173898.

Who is the listed applicant for MicroPort Orthopedics Total Hip Systems MR Labeling?

The FDA 510(k) record lists Microport Orthopedics Inc. (Mpo) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MicroPort Orthopedics Total Hip Systems MR Labeling?

The FDA product code for MicroPort Orthopedics Total Hip Systems MR Labeling is LZO.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: LZO)

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KG K260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

Официальный источник

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