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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 K122308
Device Name AXSOS DISTAL LATERAL FEMUR TS LONG PLATES
Applicant
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS
325 corporate drive
mahwah,  NJ  07430
Applicant Contact stephanie m fitts
Correspondent
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS
325 corporate drive
mahwah,  NJ  07430
Correspondent Contact stephanie m fitts
Regulation Number888.3030
Classification Product Code
HRS  
Date Received08/01/2012
Decision Date 10/01/2012
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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