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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 K864518
Device Name LACEY PRESS-FIT CONDYLAR TOTAL KNEE
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact SPIRES, JR
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact SPIRES, JR
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/17/1986
Decision Date 03/04/1987
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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