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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 K101772
Device Name TSRH(R) SPINAL SYSTEM
Applicant
Medtronic Sofamor Danek
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact LILA JOE
Correspondent
Medtronic Sofamor Danek
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact LILA JOE
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received06/24/2010
Decision Date 09/30/2010
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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