FDA 510(k)

RESPONSE™ Rib and Pelvic System

Número K: K233105 · 2024-01-20

Data da decisão2024-01-20

Código do produtoMDI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

RESPONSE™ Rib and Pelvic System is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2024-01-20 under 510(k) number K233105. The device is classified under product code MDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RESPONSE™ Rib and Pelvic System?

RESPONSE™ Rib and Pelvic System is a medical device that received FDA 510(k) clearance on 2024-01-20. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K233105.

When did RESPONSE™ Rib and Pelvic System receive FDA 510(k) clearance?

RESPONSE™ Rib and Pelvic System received FDA 510(k) clearance on 2024-01-20, under 510(k) number K233105.

Who is the listed applicant for RESPONSE™ Rib and Pelvic System?

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

What is the FDA product code for RESPONSE™ Rib and Pelvic System?

The FDA product code for RESPONSE™ Rib and Pelvic System is MDI.

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Fonte oficial

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