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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 K120991
Device Name TRANS1 INTERBODY FUSION SYSTEM
Applicant
TRANS1 INCORPORATED
301 Government Center Dr Suite 100
WILMINGTON,  NC  28403
Applicant Contact CHERYL L WAGONER
Correspondent
TRANS1 INCORPORATED
301 Government Center Dr Suite 100
WILMINGTON,  NC  28403
Correspondent Contact CHERYL L WAGONER
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/02/2012
Decision Date 08/23/2012
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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