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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(k) Number K153345
Device Name Stryker Orthopaedics Hip Systems Labeling Update
Applicant
STRYKER ORTHOPAEDICS
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact MARGARET KLIPPEL
Correspondent
STRYKER ORTHOPAEDICS
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact MARGARET KLIPPEL
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
HWC   JDI   KWL   KWY   KWZ  
LWJ   LZO   MAY   MBL   MEH  
Date Received11/19/2015
Decision Date 05/25/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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