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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K930189
Device Name ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact DIANE PATTON
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact DIANE PATTON
Regulation Number888.3560
Classification Product Code
JWH  
Date Received01/14/1993
Decision Date 08/06/1993
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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