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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 K233741
Device Name Hoffmann LRF System
Applicant
Stryker GmbH
Bohnackerweg 1
CH-2545
Selzach,  CH
Applicant Contact Amy Noccioli
Correspondent
Stryker GmbH
Bohnackerweg 1
CH-2545
Selzach,  CH
Correspondent Contact Amy Noccioli
Regulation Number888.3030
Classification Product Code
KTT  
Date Received11/22/2023
Decision Date 12/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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