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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 K130913
Device Name GENESYS SPINE APACHE LATERAL LUMBAR INTERBODY FUSION SYSTEM
Applicant
Genesys Spine
1250 Capital Of Texas Hwy So.
Bldg. Three, Suite 600
Austin,  TX  78746
Applicant Contact WILLIAM W SOWERS
Correspondent
Genesys Spine
1250 Capital Of Texas Hwy So.
Bldg. Three, Suite 600
Austin,  TX  78746
Correspondent Contact WILLIAM W SOWERS
Regulation Number888.3080
Classification Product Code
MAX  
Date Received04/02/2013
Decision Date 12/13/2013
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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