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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 K152039
Device Name Genesys Spine TiLock2 Spinal System
Applicant
Genesys Spine
1250 Capital Of Texas Highway S.
Bldg. 3 Suite 600
Austin,  Tx  78746
Applicant Contact William W Sowers
Correspondent
Genesys Spine
1250 Capital Of Texas Highway S.
Bldg. Three, Suite 600
Austin,  TX  78746
Correspondent Contact William W Sowers
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received07/22/2015
Decision Date 10/28/2015
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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