FDA 510(k)

PROLIXUS TOTAL KNEE SYSTEM

Número K: K170534 · 2017-11-09

Data da decisão2017-11-09

Código do produtoJWH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

PROLIXUS TOTAL KNEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Otis Biotech Co., Ltd.. It received FDA 510(k) clearance on 2017-11-09 under 510(k) number K170534. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PROLIXUS TOTAL KNEE SYSTEM?

PROLIXUS TOTAL KNEE SYSTEM is a medical device that received FDA 510(k) clearance on 2017-11-09. The listed applicant is Otis Biotech Co., Ltd.. The 510(k) number is K170534.

When did PROLIXUS TOTAL KNEE SYSTEM receive FDA 510(k) clearance?

PROLIXUS TOTAL KNEE SYSTEM received FDA 510(k) clearance on 2017-11-09, under 510(k) number K170534.

Who is the listed applicant for PROLIXUS TOTAL KNEE SYSTEM?

The FDA 510(k) record lists Otis Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROLIXUS TOTAL KNEE SYSTEM?

The FDA product code for PROLIXUS TOTAL KNEE SYSTEM is JWH.

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