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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 K153273
Device Name MySpine Pedicle Screw Placement Guides - LP
Applicant
Medacta International S.A.
Strada Regina
Castel San Pietro,  CH CH 6874
Applicant Contact Michael G Loiterman
Correspondent
Mapi USA, Inc.
2343 Alexandria Dr., Suite 100
Lexington,  KY  40504
Correspondent Contact Roshana Ahmed
Regulation Number888.3070
Classification Product Code
MNI  
Date Received11/12/2015
Decision Date 06/29/2016
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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