FDA 510(k)

c1Trac

Número K: K222912 · 2023-05-16

Data da decisão2023-05-16

Código do produtoITH

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

c1Trac is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Medizinsysteme GmbH. It received FDA 510(k) clearance on 2023-05-16 under 510(k) number K222912. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the c1Trac?

c1Trac is a medical device that received FDA 510(k) clearance on 2023-05-16. The listed applicant is Zimmer Medizinsysteme GmbH. The 510(k) number is K222912.

When did c1Trac receive FDA 510(k) clearance?

c1Trac received FDA 510(k) clearance on 2023-05-16, under 510(k) number K222912.

Who is the listed applicant for c1Trac?

The FDA 510(k) record lists Zimmer Medizinsysteme GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for c1Trac?

The FDA product code for c1Trac is ITH.

Outros registros que listam Zimmer Medizinsysteme GmbH como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Fonte oficial

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