FDA 510(k)

Tecomet Global Unite Short Stem Instrumentation

Номер K: K211553 · 2021-08-04

ЗаявительSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.

Дата решения2021-08-04

Код продуктаPHX

Консультативный комитетOR

РешениеSubstantially Equivalent

Описание устройства

Tecomet Global Unite Short Stem Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.. It received FDA 510(k) clearance on 2021-08-04 under 510(k) number K211553. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Tecomet Global Unite Short Stem Instrumentation?

Tecomet Global Unite Short Stem Instrumentation is a medical device that received FDA 510(k) clearance on 2021-08-04. The listed applicant is Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.. The 510(k) number is K211553.

When did Tecomet Global Unite Short Stem Instrumentation receive FDA 510(k) clearance?

Tecomet Global Unite Short Stem Instrumentation received FDA 510(k) clearance on 2021-08-04, under 510(k) number K211553.

Who is the listed applicant for Tecomet Global Unite Short Stem Instrumentation?

The FDA 510(k) record lists Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tecomet Global Unite Short Stem Instrumentation?

The FDA product code for Tecomet Global Unite Short Stem Instrumentation is PHX.

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.

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Связанные устройства (Код: PHX)

K260556Veritas Shoulder SystemRestor3D K261683Augment Off-Axis Instrument SystemZimmer, Inc.K260102Tornier Perform Reversed Гленоид и Tornier Perform Reversed Усиленный Гленоид Широкий Способности СистемыStryker Corporation (Tornier, Inc.)K261016MSS - Humeral reverse liners extensionMedacta International, SA K253992Veritas Reverse Total Shoulder SystemRestor3D K252404Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesBiomet Orthopedics

Официальный источник

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