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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 K951083
Device Name PROFORM CEMENTED FEMORAL COMPONENT
Applicant
Stelkast Company
800 Vinial St., Suite B-210
Pittsburgh,  PA  15212
Applicant Contact DONALD A STEVENS
Correspondent
Stelkast Company
800 Vinial St., Suite B-210
Pittsburgh,  PA  15212
Correspondent Contact DONALD A STEVENS
Regulation Number888.3360
Classification Product Code
JDG  
Date Received03/09/1995
Decision Date 05/22/1995
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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