FDA 510(k)

VERASENSE for Stryker Triathlon

Número K: K200665 · 2020-04-12

Data da decisão2020-04-12

Código do produtoONN

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

VERASENSE for Stryker Triathlon is the device name listed in this FDA 510(k) record. The listed applicant is Orthosensor, Inc.. It received FDA 510(k) clearance on 2020-04-12 under 510(k) number K200665. The device is classified under product code ONN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VERASENSE for Stryker Triathlon?

VERASENSE for Stryker Triathlon is a medical device that received FDA 510(k) clearance on 2020-04-12. The listed applicant is Orthosensor, Inc.. The 510(k) number is K200665.

When did VERASENSE for Stryker Triathlon receive FDA 510(k) clearance?

VERASENSE for Stryker Triathlon received FDA 510(k) clearance on 2020-04-12, under 510(k) number K200665.

Who is the listed applicant for VERASENSE for Stryker Triathlon?

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

What is the FDA product code for VERASENSE for Stryker Triathlon?

The FDA product code for VERASENSE for Stryker Triathlon is ONN.

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Outros registros que listam Orthosensor, Inc. como candidato(a)

K200587VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder K193580VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left K180459VERASENSE for Zimmer Biomet Persona K150372VERASENSE Knee System

Dispositivos Relacionados (Código: ONN)

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Fonte oficial

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