K-number	K233830
Device name	OsteoCool 2.0 RF Ablation System
Applicant	Medtronic Sofamor Danek USA, Inc.
Product code	GEI
Device class	Class II
Decision date	Feb 28, 2024
Decision	Substantially Equivalent
Regulation	878.4400

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View the full FDA submission: accessdata.fda.gov

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OsteoCool 2.0 RF Ablation System

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OsteoCool 2.0 RF Ablation System