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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, Cemented
510(k) Number K953033
Device Name PRIME CEMENTED SMALL FEMORAL STEM
Applicant
Orthopaedic Innovations, Inc.
825 S. 8th St.
Suite 700
Minneapolis,  MN  55404
Applicant Contact CAROLYN M STEELE
Correspondent
Orthopaedic Innovations, Inc.
825 S. 8th St.
Suite 700
Minneapolis,  MN  55404
Correspondent Contact CAROLYN M STEELE
Regulation Number888.3350
Classification Product Code
JDI  
Date Received06/30/1995
Decision Date 09/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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