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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K082353
Device Name MERCURY SPINAL SYSTEM
Applicant
Spinal Elements, Inc.
2744 Loker Ave. W. Suite 100
Carlsbad,  CA  92008
Applicant Contact KERRI DIMARTINO
Correspondent
Spinal Elements, Inc.
2744 Loker Ave. W. Suite 100
Carlsbad,  CA  92008
Correspondent Contact KERRI DIMARTINO
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received08/15/2008
Decision Date 01/22/2009
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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