FDA 510(k)

OsteoSync™ Ti Dental Mesh

Número K: K202918 · 2021-07-14

Data da decisão2021-07-14

Código do produtoJEY

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

OsteoSync™ Ti Dental Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Sites Medical, LLC. It received FDA 510(k) clearance on 2021-07-14 under 510(k) number K202918. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OsteoSync™ Ti Dental Mesh?

OsteoSync™ Ti Dental Mesh is a medical device that received FDA 510(k) clearance on 2021-07-14. The listed applicant is Sites Medical, LLC. The 510(k) number is K202918.

When did OsteoSync™ Ti Dental Mesh receive FDA 510(k) clearance?

OsteoSync™ Ti Dental Mesh received FDA 510(k) clearance on 2021-07-14, under 510(k) number K202918.

Who is the listed applicant for OsteoSync™ Ti Dental Mesh?

The FDA 510(k) record lists Sites Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoSync™ Ti Dental Mesh?

The FDA product code for OsteoSync™ Ti Dental Mesh is JEY.

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