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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/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(k) Number K063816
Device Name PCA ALUMINA FEMORAL HEADS
Applicant
Stryker Orthopaedics
325 Corporate Dr.
Malwah,  NJ  07430
Applicant Contact PATRICIA SETTI-LAPERCH
Correspondent
Stryker Orthopaedics
325 Corporate Dr.
Malwah,  NJ  07430
Correspondent Contact PATRICIA SETTI-LAPERCH
Regulation Number888.3353
Classification Product Code
LZO  
Date Received12/22/2006
Decision Date 02/02/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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