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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, Uncemented
510(k) Number K032110
Device Name PROCLASS PRESS FIT HIP STEM
Applicant
STELKAST COMPANY
200 HIDDEN VALLEY RD.
MCMURRAY,  PA  15317
Applicant Contact DONALD A STEVENS
Correspondent
STELKAST COMPANY
200 HIDDEN VALLEY RD.
MCMURRAY,  PA  15317
Correspondent Contact DONALD A STEVENS
Regulation Number888.3360
Classification Product Code
LWJ  
Subsequent Product Code
LZO  
Date Received07/09/2003
Decision Date 09/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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