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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 K100210
Device Name TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, T
Applicant
Trans1 Incorporated
411 Landmark Dr.
Wilmington,  NC  28412
Applicant Contact CHERYL WAGONER
Correspondent
Trans1 Incorporated
411 Landmark Dr.
Wilmington,  NC  28412
Correspondent Contact CHERYL WAGONER
Regulation Number888.3080
Classification Product Code
MAX  
Date Received01/25/2010
Decision Date 08/26/2010
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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