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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, facet screw spinal device
510(k) Number K071420
Device Name CHAMELEON FIXATION SYSTEM
Applicant
SPINEFRONTIER, INC.
100 CUMMINGS CENTER
SUITE 240C
BEVERLY,  MA  01915
Applicant Contact THOMAS CARLSON
Correspondent
SPINEFRONTIER, INC.
100 CUMMINGS CENTER
SUITE 240C
BEVERLY,  MA  01915
Correspondent Contact THOMAS CARLSON
Classification Product Code
MRW  
Date Received05/22/2007
Decision Date 01/16/2008
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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