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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 K052406
Device Name UNI-THREAD SPINAL SYSTEM
Applicant
Spine Vision, Inc.
3003 Summit Blvd., Suite 1400
Atlanta,  GA  30319
Applicant Contact LYNNETTE WHITAKER
Correspondent
Spine Vision, Inc.
3003 Summit Blvd., Suite 1400
Atlanta,  GA  30319
Correspondent Contact LYNNETTE WHITAKER
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received09/01/2005
Decision Date 11/07/2005
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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