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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 K951726
Device Name S-ROM ZTP UHMWPE ACETABULAR CUP
Applicant
JOINT MEDICAL PRODUCTS CORP.
860 CANAL ST.
STAMFORD,  CT  06902
Applicant Contact KEVIN J CROSSEN
Correspondent
JOINT MEDICAL PRODUCTS CORP.
860 CANAL ST.
STAMFORD,  CT  06902
Correspondent Contact KEVIN J CROSSEN
Regulation Number888.3350
Classification Product Code
JDI  
Date Received04/14/1995
Decision Date 06/21/1995
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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