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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 K181295
Device Name Genesys Spine AIS-C Cervical Stand-Alone System
Applicant
Genesys Spine
1250 Capital Of Texas Highway S.
Bldg. 3 Suite 600
Austin,  Tx  78746
Applicant Contact Benjamin V. Keller
Correspondent
Genesys Spine
1250 Capital Of Texas Highway S.
Bldg. 3 Suite 600
Austin,  Tx  78746
Correspondent Contact Benjamin Keller
Regulation Number888.3080
Classification Product Code
OVE  
Date Received05/16/2018
Decision Date 08/29/2018
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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