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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K121299
Device Name STERISPINEPS PEDICLE SCREW, STERISPINEPS ROD
Applicant
Safe Orthopaedics
Parc Des Bellevues, Allee R. Luxembourg-Bat. Californie
Eragny Sur Oise,  FR 95610
Applicant Contact PIERRE DUMOUCHEL
Correspondent
Safe Orthopaedics
Parc Des Bellevues, Allee R. Luxembourg-Bat. Californie
Eragny Sur Oise,  FR 95610
Correspondent Contact PIERRE DUMOUCHEL
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MNH   MNI  
Date Received04/30/2012
Decision Date 07/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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