FDA 510(k)

OsteoCool 2.0 RF Ablation System

K-Number: K233830 · 2024-02-28

ApplicantMedtronic Sofamor Danek USA, Inc.

Decision Date2024-02-28

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

OsteoCool 2.0 RF Ablation System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2024-02-28 under approval number K233830. 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 2.0 RF Ablation System?

OsteoCool 2.0 RF Ablation System is a medical device that received FDA 510(k) clearance on 2024-02-28. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K233830.

When was OsteoCool 2.0 RF Ablation System approved by the FDA?

OsteoCool 2.0 RF Ablation System received FDA 510(k) clearance on 2024-02-28, under approval number K233830.

What company makes OsteoCool 2.0 RF Ablation System?

OsteoCool 2.0 RF Ablation System is manufactured by Medtronic Sofamor Danek USA, Inc..

What is the FDA product code for OsteoCool 2.0 RF Ablation System?

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

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Official Source

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