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FDA 510(k)

ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))

Número K: K252485 · 2026-04-10

Requerente1987 Media Limited
Data da decisão2026-04-10
Código do produtoOBR
DecisãoSubstantially Equivalent

Resumo do dispositivo

ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) is the device name listed in this FDA 510(k) record. The listed applicant is 1987 Media Limited. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K252485. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))?

ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is 1987 Media Limited. The 510(k) number is K252485.

When did ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) receive FDA 510(k) clearance?

ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) received FDA 510(k) clearance on 2026-04-10, under 510(k) number K252485.

Who is the listed applicant for ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))?

The FDA 510(k) record lists 1987 Media Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))?

The FDA product code for ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size)) is OBR. This falls under the Orthopedic category.

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