FDA 510(k)

Tecomet Global Unite Short Stem Instrumentation

Número K: K211553 · 2021-08-04

RequerenteSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc.

Data da decisão2021-08-04

Código do produtoPHX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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