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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 K073144
Device Name LANX INTERVERTEBRAL BODY FUSION DEVICE
Applicant
Lanx, LLC
390 Interlocken Crescent
Suite 890
Broomfield,  CO  80021
Applicant Contact GREG CAUSEY
Correspondent
Lanx, LLC
390 Interlocken Crescent
Suite 890
Broomfield,  CO  80021
Correspondent Contact GREG CAUSEY
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/07/2007
Decision Date 01/24/2008
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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