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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K192678
Device Name Genesys Spine Binary® Lumbar Plate System
Applicant
Genesys Spine
1250 Capital of Texas Highway South
Building 3 Suite 600
Austin,  TX  78746
Applicant Contact Chloe Lance
Correspondent
Genesys Spine
1250 Capital of Texas Highway South
Building 3 Suite 600
Austin,  TX  78746
Correspondent Contact Chloe Lance
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received09/26/2019
Decision Date 10/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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