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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(k) Number K014049
Device Name EPOCA CODR STEM AND HEAD
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 Number888.3650
Classification Product Code
KWT  
Date Received12/10/2001
Decision Date 01/09/2002
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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