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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 K051223
Device Name HIPSTAR FEMORAL STEM
Applicant
STRYKER ORTHOPAEDICS
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact TIFFANI ROGERS
Correspondent
STRYKER ORTHOPAEDICS
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact TIFFANI ROGERS
Regulation Number888.3353
Classification Product Code
LZO  
Date Received05/12/2005
Decision Date 05/10/2006
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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