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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 K100037
Device Name ADVANCED VERTEBRAL SOLUTIONS EXPRESS BFD
Applicant
Advanced Vertebral Solutions, LLC
124 S. Maple St.
Ambler,  PA  19002
Applicant Contact MIKE DUGERY
Correspondent
Advanced Vertebral Solutions, LLC
124 S. Maple St.
Ambler,  PA  19002
Correspondent Contact MIKE DUGERY
Regulation Number888.3080
Classification Product Code
MAX  
Date Received01/06/2010
Decision Date 09/23/2010
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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