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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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K042127
Device Name SMITH & NEPHEW MODULAR HIP
Applicant
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact JANET JOHNSON AKIL
Correspondent
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact JANET JOHNSON AKIL
Regulation Number888.3353
Classification Product Code
MEH  
Date Received08/06/2004
Decision Date 11/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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