FDA 510(k)

FLXfit™

Número K: K171519 · 2017-09-15

Data da decisão2017-09-15

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

FLXfit™ is the device name listed in this FDA 510(k) record. The listed applicant is Expanding Orthopedics, Inc.. It received FDA 510(k) clearance on 2017-09-15 under 510(k) number K171519. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the FLXfit™?

FLXfit™ is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Expanding Orthopedics, Inc.. The 510(k) number is K171519.

When did FLXfit™ receive FDA 510(k) clearance?

FLXfit™ received FDA 510(k) clearance on 2017-09-15, under 510(k) number K171519.

Who is the listed applicant for FLXfit™?

The FDA 510(k) record lists Expanding Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLXfit™?

The FDA product code for FLXfit™ is MAX.

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