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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/Polymer, Cemented
510(k) Number K991538
Device Name OPERA CUPFLANGED ACETABULAR COMPONENTS
Applicant
Smith & Nephew, Inc., Orthopaedic Div.
1450 Brooks Rd.
Memphis,  TN  38116
Applicant Contact JANET JOHNSON GREEN
Correspondent
Smith & Nephew, Inc., Orthopaedic Div.
1450 Brooks Rd.
Memphis,  TN  38116
Correspondent Contact JANET JOHNSON GREEN
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LZO  
Date Received05/03/1999
Decision Date 06/03/1999
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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