FDA 510(k)

Orthopedic Fixation Pin

Número K: K191803 · 2020-04-14

RequerenteTinavi (Anhui) Medical Technologies Co., Ltd.

Data da decisão2020-04-14

Código do produtoJDW

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Orthopedic Fixation Pin is the device name listed in this FDA 510(k) record. The listed applicant is Tinavi (Anhui) Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2020-04-14 under 510(k) number K191803. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Orthopedic Fixation Pin?

Orthopedic Fixation Pin is a medical device that received FDA 510(k) clearance on 2020-04-14. The listed applicant is Tinavi (Anhui) Medical Technologies Co., Ltd.. The 510(k) number is K191803.

When did Orthopedic Fixation Pin receive FDA 510(k) clearance?

Orthopedic Fixation Pin received FDA 510(k) clearance on 2020-04-14, under 510(k) number K191803.

Who is the listed applicant for Orthopedic Fixation Pin?

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

What is the FDA product code for Orthopedic Fixation Pin?

The FDA product code for Orthopedic Fixation Pin is JDW.

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