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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K253202
Device Name Hoffmann LRF System
Applicant
Stryker GmbH
Bohnackerweg 1
Selzach,  CH
Applicant Contact Amy Noccioli
Correspondent
Stryker GmbH
Bohnackerweg 1
Selzach,  CH
Correspondent Contact Amy Noccioli
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
JDW  
Date Received09/26/2025
Decision Date 12/19/2025
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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