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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, Femoral Component, Cemented, Metal
510(k) Number K935078
Device Name S-ROM TOTAL HIP REPLACEMENT SYSTEM
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 Number888.3360
Classification Product Code
JDG  
Date Received10/25/1993
Decision Date 03/09/1994
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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