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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rongeur, Manual
510(k) Number K260446
Device Name Tontarra Punches and Rongeurs
Applicant
Tontarra Medizintechnik GmbH
Daimlerstraße 15
Wurmlingen,  DE 78573
Applicant Contact Andreas Birk
Correspondent
Tontarra Medizintechnik GmbH
Daimlerstraße 15
Wurmlingen,  DE 78573
Correspondent Contact Andreas Birk
Regulation Number882.4840
Classification Product Code
HAE  
Date Received02/11/2026
Decision Date 09/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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