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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K253656
Device Name OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact Jeff Sprague
Correspondent
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact Jeff Sprague
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/20/2025
Decision Date 06/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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