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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
Applicant
RENOVIS SURGICAL TECHNOLOGIES, LLC
200 HOMER AVE.
ASHLAND,  MA  01721
Applicant Contact DAVID F ROTHKOPF
Correspondent
RENOVIS SURGICAL TECHNOLOGIES, LLC
200 HOMER AVE.
ASHLAND,  MA  01721
Correspondent 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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