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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, Uncemented
510(k) Number K033313
Device Name QUATRO M FEMORAL COMPONENT
Applicant
Whiteside Biomechanics, Inc.
12634 Olive Blvd.
Creve Coeur,  MO  63141
Applicant Contact AMY CRANMER
Correspondent
Whiteside Biomechanics, Inc.
12634 Olive Blvd.
Creve Coeur,  MO  63141
Correspondent Contact AMY CRANMER
Regulation Number888.3360
Classification Product Code
LWJ  
Subsequent Product Codes
LPH   LZO  
Date Received10/15/2003
Decision Date 07/28/2004
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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