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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name screw, fixation, bone
510(k) Number K113084
Device Name RENOVIS CANNULATED SCREW SYSTEM
Original Applicant
RENOVIS SURGICAL TECHNOLOGIES, LLC
200 homer ave.
ashland,  MA  01721
Original Contact david f rothkopf
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received10/18/2011
Decision Date 12/09/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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