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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 K140010
Device Name FORTRESS PEDICLE SCREW SYSTEM
Applicant
Spineology, Inc.
7800 3rd St. N.
Suite 600
Saint Paul,  MN  55128
Applicant Contact Karen Roche
Correspondent
Spineology, Inc.
7800 3rd St. N.
Suite 600
Saint Paul,  MN  55128
Correspondent Contact Karen Roche
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received01/02/2014
Decision Date 04/23/2014
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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