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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, Constrained, Cemented Or Uncemented, Metal/Polymer
510(k) Number K870271
Device Name S-ROM POLY-DIAL CONSTRAINED SOCKET FOR ACET. CUP
Applicant
Joint Medical Products Corp.
1201 Pennsylvania Ave., NW
P.O. Box 7566
Washington,  DC  20044
Applicant Contact EUGENE I LAMBERT
Correspondent
Joint Medical Products Corp.
1201 Pennsylvania Ave., NW
P.O. Box 7566
Washington,  DC  20044
Correspondent Contact EUGENE I LAMBERT
Regulation Number888.3310
Classification Product Code
KWZ  
Date Received01/22/1987
Decision Date 04/20/1987
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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