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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 K143085
Device Name Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach
Applicant
STRYKER ORTHOPAEDICS
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact Denise Daugert
Correspondent
STRYKER ORTHOPAEDICS
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact Denise Daugert
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   KWL   KWY   KWZ   LWJ  
LZO   MAY   MBL   MEH  
Date Received10/27/2014
Decision Date 02/09/2015
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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