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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 Cemented Acetabular Component)
510(k) Number K894965
Device Name POROUS-COATED TITANIUM ACETABULAR CUP
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact MICKI ROY
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact MICKI ROY
Regulation Number888.3320
Classification Product Code
JDL  
Date Received08/07/1989
Decision Date 11/17/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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