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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, nail/blade/plate combination, multiple component
510(k) Number K110965
Device Name RENOVIS T 710 LARGE EXTERNAL FIXATION SYSTEM
Applicant
RENOVIS SURGICAL TECHNOLOGIES, LLC
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Applicant Contact DAVID J COLLETTE, MD
Correspondent
RENOVIS SURGICAL TECHNOLOGIES, LLC
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Correspondent Contact DAVID J COLLETTE, MD
Regulation Number888.3030
Classification Product Code
KTT  
Date Received04/06/2011
Decision Date 05/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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