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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 K182154
Device Name Depuy Synthes Femoral Neck System
Applicant
Synthes (USA) Products, LLC
1301 Goshen Parkway
West Chester,  PA  19380
Applicant Contact Stephan Jepards
Correspondent
Synthes (USA) Products, LLC
1301 Goshen Parkway
West Chester,  PA  19380
Correspondent Contact Stephan Jepards
Regulation Number888.3030
Classification Product Code
KTT  
Date Received08/09/2018
Decision Date 10/16/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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