FDA 510(k)

Catalyft PL Expandable Interbody System

Número K: K253011 · 2026-07-17

RequerenteMedtronic Sofamor Danek USA, Inc.

Data da decisão2026-07-17

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Catalyft PL Expandable Interbody 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 2026-07-17 under 510(k) number K253011. 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 Catalyft PL Expandable Interbody System?

Catalyft PL Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2026-07-17. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K253011.

When did Catalyft PL Expandable Interbody System receive FDA 510(k) clearance?

Catalyft PL Expandable Interbody System received FDA 510(k) clearance on 2026-07-17, under 510(k) number K253011.

Who is the listed applicant for Catalyft PL Expandable Interbody 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 Catalyft PL Expandable Interbody System?

The FDA product code for Catalyft PL Expandable Interbody System is MAX.

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Fonte oficial

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