FDA 510(k)

MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

Número K: K211313 · 2021-05-25

Data da decisão2021-05-25

Código do produtoKTT

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

MAXFRAME Multi-Axial Correction System (aka MAXFRAME) is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2021-05-25 under 510(k) number K211313. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MAXFRAME Multi-Axial Correction System (aka MAXFRAME)?

MAXFRAME Multi-Axial Correction System (aka MAXFRAME) is a medical device that received FDA 510(k) clearance on 2021-05-25. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K211313.

When did MAXFRAME Multi-Axial Correction System (aka MAXFRAME) receive FDA 510(k) clearance?

MAXFRAME Multi-Axial Correction System (aka MAXFRAME) received FDA 510(k) clearance on 2021-05-25, under 510(k) number K211313.

Who is the listed applicant for MAXFRAME Multi-Axial Correction System (aka MAXFRAME)?

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

What is the FDA product code for MAXFRAME Multi-Axial Correction System (aka MAXFRAME)?

The FDA product code for MAXFRAME Multi-Axial Correction System (aka MAXFRAME) is KTT.

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Fonte oficial

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