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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
Predetermined Change
Control Plan Authorized		 No
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