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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Integrated Fixation, Cervical
510(k) Number K233594
Device Name Genesys Spine 3DP AIS-C II Cervical Interbody System
Applicant
Genesys Spine
1250 S. Capital of Texas Highway Building 3, Suite 600
Austin,  TX  78746
Applicant Contact Andrew Davison
Correspondent
Genesys Spine
1250 S. Capital of Texas Highway Building 3, Suite 600
Austin,  TX  78746
Correspondent Contact Andrew Davison
Regulation Number888.3080
Classification Product Code
OVE  
Date Received11/08/2023
Decision Date 12/13/2023
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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