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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 K143403
Device Name Threshold Pedicular Fixation System
Applicant
Spineology, Inc.
7800 3rd St. N.
St. Paul,  MN  55128
Applicant Contact Tim Crabtree
Correspondent
Spineology, Inc.
7800 3rd St. N.
St. Paul,  MN  55128
Correspondent Contact Tim Crabtree
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received11/28/2014
Decision Date 12/18/2014
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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