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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K122639
Device Name SYNTHES SYNCAGE EVOLUTION SPACER
Applicant
SYNTHES (USA) PRODUCTS LLC
1230 Wilson Dr
West Chester,  PA  19380
Applicant Contact HEMAL MEHTA
Correspondent
SYNTHES (USA) PRODUCTS LLC
1230 Wilson Dr
West Chester,  PA  19380
Correspondent Contact HEMAL MEHTA
Regulation Number888.3080
Classification Product Code
MAX  
Date Received08/29/2012
Decision Date 05/24/2013
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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