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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 K013106
Device Name 2 PIECE MODULAR HIP STEM
Applicant
Howmedica Osteonics Corp.
59 Route 17 S.
Allendale,  NJ  07401 -1677
Applicant Contact WILLIAMR J CYMBALUK
Correspondent
Howmedica Osteonics Corp.
59 Route 17 S.
Allendale,  NJ  07401 -1677
Correspondent Contact WILLIAMR J CYMBALUK
Regulation Number888.3353
Classification Product Code
LZO  
Date Received09/17/2001
Decision Date 04/03/2002
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
Recalls CDRH Recalls
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