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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 K170528
Device Name Sterispine™ PS
Applicant
Safe Orthopaedics
Parc Des Bellevues
Allee R. Luxembourg-Bat.Califonie
Eragny Sur Oise,  FR 95610
Applicant Contact Pierre Dumouchel
Correspondent
Safe Orthopaedics
Parc Des Bellevues
Allée Rosa Luxembourg – Batiment Le Californie
Eragny Sur Oise,  FR 95610
Correspondent Contact Pierre Dumouchel
Regulation Number888.3070
Classification Product Code
NKB  
Date Received02/22/2017
Decision Date 03/09/2017
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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