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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 K170251
Device Name Threshold™ Pedicular Fixation System
Applicant
Spineology, Inc.
7800 3rd St. N.
Suite 600
Saint Paul,  MN  55128
Applicant Contact JACQUELINE HAUGE
Correspondent
Spineology, Inc.
7800 3rd St. N.
Suite 600
Saint Paul,  MN  55128
Correspondent Contact JACQUELINE A. HAUGE
Regulation Number888.3070
Classification Product Code
NKB  
Date Received01/27/2017
Decision Date 04/14/2017
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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