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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K991678
Device Name WHITESIDE BIOMECHANICS SPINAL SYSTEM
Applicant
Whiteside Biomechanics, Inc.
12634 Olive Blvd.
Creve Coeur,  MO  63141
Applicant Contact DEBRA MEYER
Correspondent
Whiteside Biomechanics, Inc.
12634 Olive Blvd.
Creve Coeur,  MO  63141
Correspondent Contact DEBRA MEYER
Regulation Number888.3060
Classification Product Code
KWQ  
Subsequent Product Codes
KWP   MNH  
Date Received05/17/1999
Decision Date 08/12/1999
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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