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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K160124
Device Name LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
Applicant
Spinevision S.A.
10 Rue De La Renaissance, Batiment E
Antony,  FR 92160
Applicant Contact Helene Plas
Correspondent
Spinevision S.A.
10 Rue De La Renaissance, Batiment E
Antony,  FR 92160
Correspondent Contact Helene Plas
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH  
Date Received01/20/2016
Decision Date 04/04/2016
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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