FDA 510(k)

TELEGRAPH® EVOLUTION Humeral Nailing System

Número K: K200127 · 2020-10-01

Data da decisão2020-10-01

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

TELEGRAPH® EVOLUTION Humeral Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is FH Industrie. It received FDA 510(k) clearance on 2020-10-01 under 510(k) number K200127. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TELEGRAPH® EVOLUTION Humeral Nailing System?

TELEGRAPH® EVOLUTION Humeral Nailing System is a medical device that received FDA 510(k) clearance on 2020-10-01. The listed applicant is FH Industrie. The 510(k) number is K200127.

When did TELEGRAPH® EVOLUTION Humeral Nailing System receive FDA 510(k) clearance?

TELEGRAPH® EVOLUTION Humeral Nailing System received FDA 510(k) clearance on 2020-10-01, under 510(k) number K200127.

Who is the listed applicant for TELEGRAPH® EVOLUTION Humeral Nailing System?

The FDA 510(k) record lists FH Industrie as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TELEGRAPH® EVOLUTION Humeral Nailing System?

The FDA product code for TELEGRAPH® EVOLUTION Humeral Nailing System is HSB.

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Fonte oficial

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