FDA 510(k)

Infinity™ OCT System

Número K: K254165 · 2026-01-21

RequerenteMedtronic Sofamor Danek USA, Inc.

Data da decisão2026-01-21

Código do produtoNKG

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Infinity™ OCT System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2026-01-21 under 510(k) number K254165. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Infinity™ OCT System?

Infinity™ OCT System is a medical device that received FDA 510(k) clearance on 2026-01-21. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K254165.

When did Infinity™ OCT System receive FDA 510(k) clearance?

Infinity™ OCT System received FDA 510(k) clearance on 2026-01-21, under 510(k) number K254165.

Who is the listed applicant for Infinity™ OCT System?

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

What is the FDA product code for Infinity™ OCT System?

The FDA product code for Infinity™ OCT System is NKG.

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Outros registros que listam Medtronic Sofamor Danek USA, Inc. como candidato(a)

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Dispositivos Relacionados (Código: NKG)

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Fonte oficial

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