FDA 510(k)

Symmetrix™ L Spinal System

Número K: K261020 · 2026-07-14

RequerenteMedtronic Sofamor Danek USA, Inc.

Data da decisão2026-07-14

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Symmetrix™ L Spinal 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 2026-07-14 under 510(k) number K261020. 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 Symmetrix™ L Spinal System?

Symmetrix™ L Spinal System is a medical device that received FDA 510(k) clearance on 2026-07-14. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K261020.

When did Symmetrix™ L Spinal System receive FDA 510(k) clearance?

Symmetrix™ L Spinal System received FDA 510(k) clearance on 2026-07-14, under 510(k) number K261020.

Who is the listed applicant for Symmetrix™ L Spinal 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 Symmetrix™ L Spinal System?

The FDA product code for Symmetrix™ L Spinal System is MAX.

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Fonte oficial

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