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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 K010282
Device Name LATERAL OFFSET PROTRACT PRESS FIT HIP STEM
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 Received01/30/2001
Decision Date 02/09/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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