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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 K940328
Device Name PRIME CEMENTED HIP SYSTEM
Applicant
Orthopaedic Innovations, Inc.
825 S. 8th St.
Suite 700
Minneapolis,  MN  55404
Applicant Contact NICHOLAS A GUSTILO
Correspondent
Orthopaedic Innovations, Inc.
825 S. 8th St.
Suite 700
Minneapolis,  MN  55404
Correspondent Contact NICHOLAS A GUSTILO
Regulation Number888.3350
Classification Product Code
JDI  
Date Received01/24/1994
Decision Date 04/07/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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