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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 Bone Graft, Lumbar
510(k) Number K161438
Device Name Genesys Spine Apache® Anterior Lumbar Interbody Fusion System
Applicant
Genesys Spine
1250 Capital Of Texas Of Highway S.,
Bldg. 3 Suite 600
Austin,  TX  78746
Applicant Contact BRIAN BERGERON
Correspondent
Genesys Spine
1250 Capital Of Texas Of Highway S.,
Bldg. 3 Suite 600
Austin,  TX  78746
Correspondent Contact Brian Bergeron
Regulation Number888.3080
Classification Product Code
MAX  
Date Received05/24/2016
Decision Date 11/08/2016
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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