FDA 510(k)

OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System

Número K: K253656 · 2026-06-05

RequerenteMedtronic Sofamor Danek USA, Inc.

Data da decisão2026-06-05

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation 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 2026-06-05 under 510(k) number K253656. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System?

OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System is a medical device that received FDA 510(k) clearance on 2026-06-05. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K253656.

When did OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System receive FDA 510(k) clearance?

OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System received FDA 510(k) clearance on 2026-06-05, under 510(k) number K253656.

Who is the listed applicant for OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation 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 OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System?

The FDA product code for OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System is GEI.

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