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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 K871852
Device Name COXA ACETABULAR CUP
Applicant
Thackray USA
R.D. #3 Box 237
Welisewitz Rd.
Ringoes,  NJ  08551
Applicant Contact RANDOLPH L COOKE
Correspondent
Thackray USA
R.D. #3 Box 237
Welisewitz Rd.
Ringoes,  NJ  08551
Correspondent Contact RANDOLPH L COOKE
Regulation Number888.3350
Classification Product Code
JDI  
Date Received05/12/1987
Decision Date 02/18/1988
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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