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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K032398
Device Name PLUS PIVOT LINK UNIVERSAL SYSTEM
Applicant
Spine Vision, Inc.
3003 Summit Blvd. Suite 1500
Atlanta,  GA  30319
Applicant Contact LYNETTE WHITAKER
Correspondent
Spine Vision, Inc.
3003 Summit Blvd. Suite 1500
Atlanta,  GA  30319
Correspondent Contact LYNETTE WHITAKER
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received08/04/2003
Decision Date 10/31/2003
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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