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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 Interlaminal
510(k) Number K013312
Device Name P.L.U.S. SYSTEM (PIVOT LINK UNIVERSAL SYSTEM)
Applicant
SPINEVISION, INC.
3003 SUMMIT BLVD.; STE 1500
ATLANTA,  GA  30319
Applicant Contact LYNNETTE WHITAKER
Correspondent
SPINEVISION, INC.
3003 SUMMIT BLVD.; STE 1500
ATLANTA,  GA  30319
Correspondent Contact LYNNETTE WHITAKER
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received10/04/2001
Decision Date 02/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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