FDA 510(k)

Titanium TomoFix Medial High Tibia Plate Anatomical

Número K: K180213 · 2018-10-19

Data da decisão2018-10-19

Código do produtoHRS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Titanium TomoFix Medial High Tibia Plate Anatomical is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2018-10-19 under 510(k) number K180213. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Titanium TomoFix Medial High Tibia Plate Anatomical?

Titanium TomoFix Medial High Tibia Plate Anatomical is a medical device that received FDA 510(k) clearance on 2018-10-19. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K180213.

When did Titanium TomoFix Medial High Tibia Plate Anatomical receive FDA 510(k) clearance?

Titanium TomoFix Medial High Tibia Plate Anatomical received FDA 510(k) clearance on 2018-10-19, under 510(k) number K180213.

Who is the listed applicant for Titanium TomoFix Medial High Tibia Plate Anatomical?

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

What is the FDA product code for Titanium TomoFix Medial High Tibia Plate Anatomical?

The FDA product code for Titanium TomoFix Medial High Tibia Plate Anatomical is HRS.

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