FDA 510(k)

Spider Frame External Fixation System

Número K: K170482 · 2017-09-27

RequerenteTasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S

Data da decisão2017-09-27

Código do produtoKTT

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Spider Frame External Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S. It received FDA 510(k) clearance on 2017-09-27 under 510(k) number K170482. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Spider Frame External Fixation System?

Spider Frame External Fixation System is a medical device that received FDA 510(k) clearance on 2017-09-27. The listed applicant is Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S. The 510(k) number is K170482.

When did Spider Frame External Fixation System receive FDA 510(k) clearance?

Spider Frame External Fixation System received FDA 510(k) clearance on 2017-09-27, under 510(k) number K170482.

Who is the listed applicant for Spider Frame External Fixation System?

The FDA 510(k) record lists Tasarimmed Tibbi Mamuller Sanayi VE Ticaret A.S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spider Frame External Fixation System?

The FDA product code for Spider Frame External Fixation System is KTT.

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