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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
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