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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K242988
Device Name Genostis Osteosynthesis System
Applicant
Genostis AF
Kirchbergstrasse 160
Burgdorf,  CH 3400
Applicant Contact Sabine Söhndel
Correspondent
Wagoner Consulting, LLC
5215 Crosswinds Dr.
Wilmington,  NC  28409
Correspondent Contact Cheryl Wagoner
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received09/26/2024
Decision Date 06/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
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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