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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Partial Ossicular Replacement
510(k) Number K260718
Device Name mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)
Applicant
MED-EL Elektromedizinische Geräte GmbH
Fürstenweg 77a
Innsbruck,  AT 6020
Applicant Contact Vladislav Morozov
Correspondent
MED-EL Elektromedizinische Geräte GmbH
Fürstenweg 77a
Innsbruck,  AT 6020
Correspondent Contact Vladislav Morozov
Regulation Number874.3450
Classification Product Code
ETB  
Date Received03/05/2026
Decision Date 04/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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