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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 K150507
Device Name Santis Pedicle Screw System
Applicant
Lanterna Medical Technologies
294 Rorschacherstrasse
St.Gallen,  CH 9016
Applicant Contact Horace Hale
Correspondent
Silver Pine Consulting, LLC
11821 Bramble Cove Dr.
Fr. Myers,  FL  33905
Correspondent Contact Rich Jansen
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received02/26/2015
Decision Date 04/03/2015
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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