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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spondylolisthesis spinal fixation
510(k) Number K111940
Device Name S 100 PEDICLE SCREW SYSTEM
Applicant
RENOVIS SURGICAL TECHNOLOGIES, LLC
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Applicant Contact J.D. WEBB
Correspondent
RENOVIS SURGICAL TECHNOLOGIES, LLC
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Correspondent Contact J.D. WEBB
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received07/08/2011
Decision Date 05/15/2012
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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