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FDA 510(k)

OsteoCool RF Ablation System

K-Number: K182497 · 2019-01-15

ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2019-01-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OsteoCool RF Ablation System is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2019-01-15 under approval number K182497. 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 RF Ablation System is a medical device that received FDA 510(k) clearance on 2019-01-15. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K182497.

When was OsteoCool RF Ablation System approved by the FDA?

OsteoCool RF Ablation System received FDA 510(k) clearance on 2019-01-15, under approval number K182497.

What company makes OsteoCool RF Ablation System?

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

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

The FDA product code for OsteoCool 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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