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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 K072289
Device Name SPINEFRONTIER DORADO VBR
Applicant
Spinefrontier, Inc.
100 Cummings Center
Suite 240c
Beverly,  MA  01915
Applicant Contact TOM CARLSON
Correspondent
Spinefrontier, Inc.
100 Cummings Center
Suite 240c
Beverly,  MA  01915
Correspondent Contact TOM CARLSON
Regulation Number888.3080
Classification Product Code
MAX  
Date Received08/16/2007
Decision Date 11/01/2007
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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