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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 K031455
Device Name CONKLUSION PEDICLE SCREW SYSTEM
Applicant
Signus Medical, LLC
6713 Lakeway Dr.
Chanhassen,  MN  55317
Applicant Contact THOMAS HOGHAUG
Correspondent
Signus Medical, LLC
6713 Lakeway Dr.
Chanhassen,  MN  55317
Correspondent Contact THOMAS HOGHAUG
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received05/07/2003
Decision Date 10/22/2003
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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