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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, Cervical
510(k) Number K130317
Device Name GENESYS SPINE APACHE IBFD STAR CERVICAL 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
ODP  
Date Received02/08/2013
Decision Date 12/11/2013
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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