FDA 510(k)

Responsive Orthopedics Total Hip Arthroplasty System

Número K: K163585 · 2017-06-02

Data da decisão2017-06-02

Código do produtoLZO

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Responsive Orthopedics Total Hip Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Responsive Orthopedics, LLC. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K163585. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Responsive Orthopedics Total Hip Arthroplasty System?

Responsive Orthopedics Total Hip Arthroplasty System is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Responsive Orthopedics, LLC. The 510(k) number is K163585.

When did Responsive Orthopedics Total Hip Arthroplasty System receive FDA 510(k) clearance?

Responsive Orthopedics Total Hip Arthroplasty System received FDA 510(k) clearance on 2017-06-02, under 510(k) number K163585.

Who is the listed applicant for Responsive Orthopedics Total Hip Arthroplasty System?

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

What is the FDA product code for Responsive Orthopedics Total Hip Arthroplasty System?

The FDA product code for Responsive Orthopedics Total Hip Arthroplasty System is LZO.

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Fonte oficial

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