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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 K113518
Device Name ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
Applicant
Spinefrontier, Inc.
500 Cummings Center, Suite 3500
Beverly,  MA  01915
Applicant Contact CHRISTOPHER CHANG
Correspondent
Spinefrontier, Inc.
500 Cummings Center, Suite 3500
Beverly,  MA  01915
Correspondent Contact CHRISTOPHER CHANG
Regulation Number888.3080
Classification Product Code
ODP  
Date Received11/29/2011
Decision Date 02/16/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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