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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 K151770
Device Name Libra Pedicle Screw System
Applicant
Spinal Balance, Inc.
1510 N. Westwood Ave.
Toledo,  OH  43606
Applicant Contact Anand Agarwal
Correspondent
Backroads Consulting, Inc.
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E. Warden
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received06/30/2015
Decision Date 11/20/2015
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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