FDA 510(k)

INJECTION PIN (KIP(02031-02061) (03031-03061))

Número K: K221697 · 2023-03-03

Data da decisão2023-03-03

Código do produtoNDN

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

INJECTION PIN (KIP(02031-02061) (03031-03061)) is the device name listed in this FDA 510(k) record. The listed applicant is Slk Ortho, LLC. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K221697. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the INJECTION PIN (KIP(02031-02061) (03031-03061))?

INJECTION PIN (KIP(02031-02061) (03031-03061)) is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Slk Ortho, LLC. The 510(k) number is K221697.

When did INJECTION PIN (KIP(02031-02061) (03031-03061)) receive FDA 510(k) clearance?

INJECTION PIN (KIP(02031-02061) (03031-03061)) received FDA 510(k) clearance on 2023-03-03, under 510(k) number K221697.

Who is the listed applicant for INJECTION PIN (KIP(02031-02061) (03031-03061))?

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

What is the FDA product code for INJECTION PIN (KIP(02031-02061) (03031-03061))?

The FDA product code for INJECTION PIN (KIP(02031-02061) (03031-03061)) is NDN.

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