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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 K102249
Device Name EXPEDIUM SPINE SYSTEM
Applicant
Depuy Spine, A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact DAPHNEY GERMAIN
Correspondent
Depuy Spine, A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact DAPHNEY GERMAIN
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received08/09/2010
Decision Date 12/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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