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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K083872
Device Name IMNS MEDACTA NAVIGATION SYSTEM
Applicant
Medacta International S.A.
13721 Via Tres Vista
San Diego,  CA  92129
Applicant Contact NATLIE J KENNEL
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
HAW  
Date Received12/29/2008
Decision Date 01/15/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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