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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 Intervertebral Body
510(k) Number K063158
FOIA Releasable 510(k) K063158
Device Name SYNTHES ANTEGRA SYSTEM
Applicant
Synthes Spine Co.Lp
1302 Wrights Lane E.
West Chester,  PA  19380
Applicant Contact SUSAN LEWANDOWSKI
Correspondent
Synthes Spine Co.Lp
1302 Wrights Lane E.
West Chester,  PA  19380
Correspondent Contact SUSAN LEWANDOWSKI
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/17/2006
Decision Date 11/14/2006
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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