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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, Porous Uncemented
510(k) Number K010241
Device Name PROTRACT PRESS FIT HIP STEM-HA COATED
Applicant
Stelkast Company
800 Vinial St. #210
Pittsburgh,  PA  15212
Applicant Contact DONALD A STEVENS
Correspondent
Stelkast Company
800 Vinial St. #210
Pittsburgh,  PA  15212
Correspondent Contact DONALD A STEVENS
Regulation Number888.3358
Classification Product Code
LPH  
Date Received01/25/2001
Decision Date 02/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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