FDA 510(k)

IRENE Locking Compression Plate System

Número K: K151508 · 2016-02-25

RequerenteTianjin Zhengtian Medical Instrument Co., Ltd.

Data da decisão2016-02-25

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

IRENE Locking Compression Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Tianjin Zhengtian Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2016-02-25 under 510(k) number K151508. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the IRENE Locking Compression Plate System?

IRENE Locking Compression Plate System is a medical device that received FDA 510(k) clearance on 2016-02-25. The listed applicant is Tianjin Zhengtian Medical Instrument Co., Ltd.. The 510(k) number is K151508.

When did IRENE Locking Compression Plate System receive FDA 510(k) clearance?

IRENE Locking Compression Plate System received FDA 510(k) clearance on 2016-02-25, under 510(k) number K151508.

Who is the listed applicant for IRENE Locking Compression Plate System?

The FDA 510(k) record lists Tianjin Zhengtian Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRENE Locking Compression Plate System?

The FDA product code for IRENE Locking Compression Plate System is HRS.

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