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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 Cemented, Osteophilic Finish
510(k) Number K110807
Device Name ABG II MONOLITHIC HIP STEM
Applicant
Stryker Corp.
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact STEPHANIE FITTS
Correspondent
Stryker Corp.
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact STEPHANIE FITTS
Regulation Number888.3353
Classification Product Code
MAY  
Subsequent Product Codes
LPH   LZO   MBL   MEH  
Date Received03/23/2011
Decision Date 05/25/2011
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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