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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 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 2019-01-15 under 510(k) 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. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K182497.

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

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

Who is the listed applicant for OsteoCool 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?

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

Other records listing Medtronic Sofamor Danek USA, Inc. as applicant

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Related Devices (Code: 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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