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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 K092774
Device Name ATLAS INTERVERTEBRAL BODY CAGE
Applicant
Spinal Edge, LLC
33650 Reserve Way
Avon,  OH  44011
Applicant Contact CHRISTINA VACCA
Correspondent
Spinal Edge, LLC
33650 Reserve Way
Avon,  OH  44011
Correspondent Contact CHRISTINA VACCA
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
MQP  
Date Received09/09/2009
Decision Date 02/02/2010
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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