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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 K172469
Device Name TiLock Modular Spinal System
Applicant
Genesys Spine
1250 Capital Of Texas Of Hwy. S.,
Bldg. 3 Suite 600
Austin,  TX  78746
Applicant Contact Brian J. Bergeron
Correspondent
Genesys Spine
1250 Capital Of Texas Hwy. S.
Bldg. 3 Suite 600
Austin,  Tx  78746
Correspondent Contact Brian J. Bergeron
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ  
Date Received08/15/2017
Decision Date 11/30/2017
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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