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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 K855166
Device Name THACKRAY TOTAL CONDYLAR KNEES
Applicant
Thackray USA
R.D. #3 Box 237
Welisewitz Rd.
Ringoes,  NJ  08551
Applicant Contact SER.
Correspondent
Thackray USA
R.D. #3 Box 237
Welisewitz Rd.
Ringoes,  NJ  08551
Correspondent Contact SER.
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/26/1985
Decision Date 03/13/1986
Decision Substantially Equivalent (SESE)
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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