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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 K131425
Device Name NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
Applicant
Medtronic Navigation, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Applicant Contact REGINA HOLMES
Correspondent
Medtronic Navigation, Inc.
1800 Pyramid Pl.
Memphis,  TN  38132
Correspondent Contact REGINA HOLMES
Regulation Number882.4560
Classification Product Code
OLO  
Subsequent Product Code
MAX  
Date Received05/17/2013
Decision Date 08/14/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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