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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 K162576
Device Name FORTEZZA Spinal Stabilization System
Applicant
Osso Surgical
2150 W 43rd St.
Chicago,  IL  60609
Applicant Contact Basheer Hassan
Correspondent
Mrc-X, LLC
3416 Roxee Run Cove
Bartlett,  TN  38133
Correspondent Contact Kimberly Strohkirch
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI   OSH  
Date Received09/15/2016
Decision Date 11/10/2016
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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