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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 K082270
Device Name OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM
Applicant
Vertiflex, Inc.
1351 Calle Avanzado
San Clamente,  CA  92673
Applicant Contact STEVE REITZLER
Correspondent
Vertiflex, Inc.
1351 Calle Avanzado
San Clamente,  CA  92673
Correspondent Contact STEVE REITZLER
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received08/11/2008
Decision Date 09/16/2008
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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