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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K073232
Device Name INDUS ANTERIOR CERVICAL PLATE SYSTEM, MODEL IM3XXX
Applicant
Spinefrontier, Inc.
100 Cummings Center
Suite 240c
Beverly,  MA  01915
Applicant Contact THOMAS A CARLSON
Correspondent
Spinefrontier, Inc.
100 Cummings Center
Suite 240c
Beverly,  MA  01915
Correspondent Contact THOMAS A CARLSON
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received11/15/2007
Decision Date 02/20/2008
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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