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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 K130948
Device Name C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
Applicant
Southern Spine, LLC
111 Laurel Ridge Dr.
Alpharetta,  GA  30004
Applicant Contact JULIE STEPHENS
Correspondent
Southern Spine, LLC
111 Laurel Ridge Dr.
Alpharetta,  GA  30004
Correspondent Contact JULIE STEPHENS
Regulation Number888.3080
Classification Product Code
ODP  
Date Received04/05/2013
Decision Date 08/14/2013
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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