FDA 510(k)

S4 Screw System™

Número K: K162171 · 2017-09-07

Data da decisão2017-09-07

Código do produtoHWC

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

S4 Screw System™ is the device name listed in this FDA 510(k) record. The listed applicant is Subchondral Solutions. It received FDA 510(k) clearance on 2017-09-07 under 510(k) number K162171. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the S4 Screw System™?

S4 Screw System™ is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Subchondral Solutions. The 510(k) number is K162171.

When did S4 Screw System™ receive FDA 510(k) clearance?

S4 Screw System™ received FDA 510(k) clearance on 2017-09-07, under 510(k) number K162171.

Who is the listed applicant for S4 Screw System™?

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

What is the FDA product code for S4 Screw System™?

The FDA product code for S4 Screw System™ is HWC. This falls under the Cardiovascular category.

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