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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, Hemi-, Femoral, Metal
510(k) Number K962646
Device Name PRIME MODULAR ENDO HEAD
Applicant
Orthopaedic Innovations, Inc.
825 S. 8th St.
Suite 700
Minneapolis,  MN  55404
Applicant Contact CAROLYN M STEELE-HUSTEN
Correspondent
Orthopaedic Innovations, Inc.
825 S. 8th St.
Suite 700
Minneapolis,  MN  55404
Correspondent Contact CAROLYN M STEELE-HUSTEN
Regulation Number888.3360
Classification Product Code
KWL  
Date Received07/08/1996
Decision Date 09/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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