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FDA 510(k)

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

K-Number: K253656 · 2026-06-05

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2026-06-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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