FDA 510(k)

Kisar Stratford SI Screw System

Número K: K220274 · 2023-04-24

Data da decisão2023-04-24

Código do produtoOUR

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kisar Stratford SI Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Anjali Investments L.L.C. It received FDA 510(k) clearance on 2023-04-24 under 510(k) number K220274. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Kisar Stratford SI Screw System?

Kisar Stratford SI Screw System is a medical device that received FDA 510(k) clearance on 2023-04-24. The listed applicant is Anjali Investments L.L.C. The 510(k) number is K220274.

When did Kisar Stratford SI Screw System receive FDA 510(k) clearance?

Kisar Stratford SI Screw System received FDA 510(k) clearance on 2023-04-24, under 510(k) number K220274.

Who is the listed applicant for Kisar Stratford SI Screw System?

The FDA 510(k) record lists Anjali Investments L.L.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kisar Stratford SI Screw System?

The FDA product code for Kisar Stratford SI Screw System is OUR.

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