FDA 510(k)

Sistema Espinal Anteralign com Tecnologia de Superfície Titan nanoLOCK

Número K: K214010 · 2022-04-12

Data da decisão2022-04-12

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Anteralign Spinal System with Titan nanoLOCK Surface Technology is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA. It received FDA 510(k) clearance on 2022-04-12 under 510(k) number K214010. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Anteralign Spinal System with Titan nanoLOCK Surface Technology?

Anteralign Spinal System with Titan nanoLOCK Surface Technology is a medical device that received FDA 510(k) clearance on 2022-04-12. The listed applicant is Medtronic Sofamor Danek USA. The 510(k) number is K214010.

When did Anteralign Spinal System with Titan nanoLOCK Surface Technology receive FDA 510(k) clearance?

Anteralign Spinal System with Titan nanoLOCK Surface Technology received FDA 510(k) clearance on 2022-04-12, under 510(k) number K214010.

Who is the listed applicant for Anteralign Spinal System with Titan nanoLOCK Surface Technology?

The FDA 510(k) record lists Medtronic Sofamor Danek USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anteralign Spinal System with Titan nanoLOCK Surface Technology?

The FDA product code for Anteralign Spinal System with Titan nanoLOCK Surface Technology is MAX.

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Fonte oficial

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