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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 K233830
Device Name OsteoCool™ 2.0 RF Ablation System
Applicant
Medtronic Sofamor Danek USA Inc.
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact Jeff Sprague
Correspondent
Medtronic Sofamor Danek USA Inc.
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact Denise Gaston
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/01/2023
Decision Date 02/28/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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