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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 K100481
Device Name SMITH & NEPHEW MDF MODULAR SLEEVE
Applicant
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Applicant Contact NATALIE P WILLIAMS
Correspondent
Smith & Nephew, Inc.
1450 Brooks Rd.
Memphus,  TN  38116
Correspondent Contact NATALIE P WILLIAMS
Regulation Number888.3353
Classification Product Code
MEH  
Date Received02/18/2010
Decision Date 07/15/2010
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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